Cardiac treatment system and method

ABSTRACT

Devices and methods for providing localized pressure to a region of a patient&#39;s heart to improve heart functioning. The devices include a cardiac jacket made of a flexible biocompatible material and at least one inflatable bladder disposed on an interior surface of the jacket. Inflation of the bladder causes the bladder to expand to exert localized pressure against a region of the heart. In some cases, a phase-change material is filled into the bladder as a liquid and the material solidifies at body temperature. In some cases, a positioning tool is used prior to the implantation of the jacket in order to determine effective positions for the inflatable bladder(s) to be located on the heart to improve heart functioning.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Ser.No. 62/662,944, filed Apr. 26, 2018, the content of which application isincorporated herein by reference in its entirety.

TECHNICAL FIELD

The present disclosure relates to medical devices for treating heartdiseases and valvular dysfunction, including valvular regurgitation.

BACKGROUND OF THE INVENTION

Various compression-style systems currently exist for treating heartdiseases and conditions such as congestive heart disease and valvulardysfunction. These systems typically involve either: (a) jackets thatare placed around the heart to limit heart expansion to treat congestiveheart disease, or (b) bands that are placed around the heart withfillable chambers to exert localized pressure to re-form the shape ofheart valves, for example to minimize valve leakage.

An example of the former is found in U.S. Published Patent Application2010/0160721 entitled “Cardiac Support Device With DifferentialCompliance.” This device is used to treat congestive heart disease.Congestive heart disease is the progressive enlargement of the heart.This enlargement requires the heart to perform an increasing amount ofwork. In time, the heart cannot supply an adequate amount of blood,resulting in a patient that is fatigued and in discomfort. The cardiacsupport device of U.S. Application 2101/0160721 limits heart expansionusing a flexible jacket positioned around the heart. An example of thesecond type of system is found in Mardil, Inc.'s U.S. Pat. No. 8,092,363entitled “Heart Band With Fillable Chambers To Modify Heart ValveFunction.” This device has fillable chambers that exert inward radialforces on heart valves. The fillable chambers are disposed within innerand outer layers of a silicone rubber band.

SUMMARY

Some embodiments described herein provide a system including an cardiacimplant structure configured to be positioned around the exterior of anepicardial surface of a heart. Such a system can be used, for example,to treat various heart conditions, including but not limited tofunctional mitral regurgitation (“FMR”), tricuspid valve regurgitation,congestive heart failure, or a combination thereof. The implantstructure can include a mesh body having a leading hem region configuredto elastically flex and engage with an atrial-ventricular groove of theheart, and one or more fillable bladders mounted to the mesh body at oneor more predetermined locations so as to provide localized pressure at atargeted surface regions of the heart spaced apart from theatrial-ventricular groove. The implant structure can be equipped withradiopaque markers at selected locations along the leading hem region,along or within the fillable bladders, or a combination thereof, so thatthe relative positioning of the implant structure and the targetedlandmarks of the heart can be readily identified both during and afteran implantation procedure. For example, in particular embodiments, thefillable bladders (equipped with markers along a periphery thereof) canbe coupled to the mesh body at a specific location to exert a localizedpressure on the posterior lateral surface of the heart to therebydeflect the “P2” portion of the posterior leaflet of the mitral valve totreat FMR. Accordingly, the combined components of the implant structurecan be configured to apply supporting or deformation forces to multipletargeted regions of the heart in a manner that supports the ventriclewalls of the heart, particular valve structures of the heart, and(optionally) the atrial-ventricular groove of the heart.

In one aspect, this disclosure is directed to a cardiac implant forimplantation around an exterior of a heart. The implant includes: (i) animplant body comprising a mesh material that is formed into a generallytubular configuration, the implant body comprising a leading end portiondefining an open leading end and a trailing end portion defining an opentrailing end of a diameter that is less than a diameter of the openleading end; and (ii) a fillable bladder mounted to the implant body andpositioned relative to the open leading end such that, when the leadingend portion is positioned in an atrial-ventricular groove of the heart,the fillable bladder is positionable on an exterior of a heart wall. Thefillable bladder includes side walls with one or more undulations.

Such a cardiac implant may optionally include one or more of thefollowing features. The side walls with one or more undulations mayfacilitate expansion of the fillable bladder without stretching. Thefillable bladder may include: (a) an inner bladder layer positioned withrespect to the mesh material of the implant body to face inwardly towardthe exterior of the heart wall when the leading end portion ispositioned in the atrial-ventricular groove of the heart, and (b) anouter bladder layer position opposite from the inner bladder layer. Theinner bladder layer may include the side walls with one or moreundulations. The inner bladder layer may include a pressure-exertingsurface defined within a periphery of the side walls with one or moreundulations. The side walls with one or more undulations may include atleast two undulations. The cardiac implant may also include at least afirst radiopaque marker positioned along a periphery of the fillablebladder, and at least a second radiopaque marker positioned along aperiphery of the leading end portion proximate to the leading open end.

In another aspect, this disclosure is directed to a cardiac implant forimplantation around an exterior of a heart. The implant includes: (1) animplant body comprising a mesh material that is formed into a generallytubular configuration, the implant body comprising a leading end portiondefining an open leading end and a trailing end portion defining an opentrailing end of a diameter that is less than a diameter of the openleading end; and (2) a fillable bladder mounted to the implant body andpositioned relative to the open leading end such that, when the leadingend portion is positioned in an atrial-ventricular groove of the heart,the fillable bladder is positionable on an exterior of a heart wall. Thefillable bladder includes a fabric layer positioned to face inwardlytoward the exterior of the heart wall when the leading end portion ispositioned in the atrial-ventricular groove of the heart.

Such a cardiac implant may optionally include one or more of thefollowing features. The fillable bladder may include side walls with oneor more undulations. The fabric layer may be positioned on apressure-exerting surface of the inflatable bladder defined within aperiphery of the side walls with one or more undulations.

In another aspect, this disclosure is directed to a method of treatingheart valve insufficiency. The method includes introducing a cardiacimplant into a patient. The implant includes: (a) an implant body formedinto a generally tubular configuration, the implant body comprising aleading end portion with an open leading end and a trailing end portionwith an open trailing end; (b) a first fillable bladder attached to theimplant body; and (c) a second fillable bladder attached to the implantbody. The method also includes positioning the cardiac implant so that:(i) the leading end portion is positioned in an atrial-ventriculargroove of the heart, (ii) the first fillable bladder is positionedadjacent to a first exterior surface of the heart that is adjacent to amitral valve annulus, and (iii) the second fillable bladder ispositioned adjacent to a second exterior surface of the heart that isadjacent to papillary muscles that control chordae attached to mitralvalve leaflets. The method also includes closing the open trailing endof the trailing end portion of the implant body so that the implant bodyencompasses an apex of the heart.

Such a method of treating heart valve insufficiency may optionallyinclude one or more of the following features. The method may alsoinclude filling the first fillable bladder to apply localized pressureon the first exterior surface of the heart so as to modify a shape ofthe mitral valve annulus; and filling the second fillable bladder toapply localized pressure on the second exterior surface of the heart soas to modify a position of the papillary muscles that control chordaeattached to the mitral valve leaflets.

In another aspect, this disclosure is directed to a method of treatingheart valve insufficiency. The method includes introducing a cardiacimplant into a patient. The implant includes: (A) an implant body formedinto a generally tubular configuration, the implant body comprising aleading end portion with an open leading end and a trailing end portionwith an open trailing end; and (B) a fillable bladder attached to theimplant body, wherein the fillable bladder includes a fabric layerpositioned to contact a heart when the implant body is positioned aroundthe heart. The method also includes positioning the cardiac implant sothat: (i) the leading end portion is positioned in an atrial-ventriculargroove of the heart, and (ii) the fillable bladder is positionedadjacent to an exterior surface of the heart that is adjacent to amitral valve annulus. The method also includes closing the open trailingend of the trailing end portion of the implant body so that the implantbody encompasses an apex of the heart.

Such a method of treating heart valve insufficiency may optionallyinclude one or more of the following features. The method may alsoinclude allowing, while the cardiac implant is on the heart, a timeperiod to lapse to allow for growth of epicardial tissue into the fabriclayer. The method may also include, after the time period has lapsed,filling the fillable bladder to apply localized pressure on the exteriorsurface of the heart so as to modify a shape of the mitral valveannulus. In some cases, the time period is at least two weeks. In somecases, the time period is at least four weeks.

These and other embodiments described herein may provide one or more ofthe following benefits. First, some embodiments include an implantstructure having a combination of components that operate tocontemporaneously apply forces for supporting or deformation differenttargeted regions of the heart. For example, the implant structure ofparticular embodiments of the system described can be configured tocontemporaneously apply a localized pressure to a defined area of theposterior lateral surface of the heart while also applying a restrainingforce of to the ventricle walls of the heart and (optionally) acompressive supporting force to the atrial-ventricular groove of theheart.

Second, some embodiments of the system or method described herein can beused to treat various heart conditions, including but not limited tofunctional mitral valve regurgitation (“FMR”), tricuspid valveregurgitation, congestive heart failure, or a combination thereof. Uponimplantation, implantation structure can apply forces for supporting ordeformation regions of the heart in a manner that eliminates or reducesthe symptoms of these conditions and that improves blood flow from theheart.

Third, some embodiments of the system or method described herein caninclude a delivery device configured to advantageously advanced theimplant structure to the heart through a relatively small opening of aselected intercostal space proximate to the apex of the heart.Optionally, each delivery device can be configured as a disposable,single-use instrument that is pre-loaded with the implant structure andpackaged in a sterilized kit. As such, the clinician can simply select adelivery device bearing the selected size of implant structure(pre-installed on a barrel of the delivery device by during manufactureor assembly) from a plurality of delivery devices in a hospitalinventory. After the implant structure in implanted, the delivery devicecan be conveniently discarded along with other disposables from theoperating room.

Fourth, in some embodiments, the implant structure can be arranged onthe delivery device in a predetermined orientation relative to thehandle of the delivery device. In such circumstances, the fillablebladder of the implant structure may be predisposed for advancementalong a targeted side of the heart (e.g., a posterior side) when thehandle of the delivery device is held in a selected position external tothe opening in the chest, thereby assisting the clinician in aligningthe fillable bladder with the targeted surface region of the heart.

Fifth, in particular embodiments, the implant structure can be equippedwith radiopaque markers positioned at an advantageous combination oflocations along the leading end, along the fillable bladder, or both. Assuch, during use of the implant structure, the relative positioning ofthe implant structure and the targeted landmarks of the heart can bereadily identified both during and after an implantation procedure.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of such embodiments will be apparent from thedescription and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an exploded view showing an implant for treating a heart andthe heart upon which the implant may be implanted, in accordance withsome embodiments.

FIG. 1B is a perspective cutaway view of a heart with the implant ofFIG. 1A implanted on the heart.

FIG. 2A is a perspective side view of an implant for treating a heart,in accordance with some embodiments.

FIG. 2B is a perspective end view of the implant of FIG. 2A showing afillable bladder in a deflated configuration.

FIG. 2C is a perspective end view of the implant of FIG. 2A showing thefillable bladder in an inflated configuration.

FIG. 3 is an exploded view of a fillable bladder, in accordance withsome embodiments.

FIG. 4A is a perspective view of another implant for treating a heartthat is positioned on a patient's heart, in accordance with someembodiments.

FIG. 4B is a perspective view of another implant for treating a heartincluding three optional bladder locations at the mitral valve,papillary muscle and tricuspid valve, in accordance with someembodiments.

FIG. 5 is a sectional elevation view through one of the inflatablebladders of FIGS. 4A and 4B.

FIG. 6A is a perspective side view of an implant delivery device that isloaded with an implant, in accordance with some embodiments.

FIG. 6B is a perspective side view of the implant delivery device ofFIG. 6A with a heart stabilizer in an extended position.

FIG. 6C is a distal end view of the implant delivery device of FIG. 6A.

FIG. 7 is a front view of a low friction (e.g., lubricious) stripcomponent for use with the implant delivery device of FIG. 6A, inaccordance with some embodiments.

FIGS. 8A-8E are multiple perspective views of an implant delivery devicewith the heart stabilizer in an extended position, in accordance withsome embodiments.

FIG. 8F is a perspective view of the implant delivery device of FIGS.8A-8E, with the heart stabilizer in a retracted position.

FIG. 8G is a perspective view of the implant delivery device of FIGS.8A-8E, with the heart stabilizer in a retracted position and multipleelongate actuator arms in fully extended positions.

FIG. 9A shows a perspective view of the implant delivery device of FIGS.8A-8E, with one of its elongate arms in a partially extended position.

FIG. 9B is a partial perspective and partial cross-sectional view of theimplant delivery device of FIG. 9A, the cross section taken along lines9B shown in FIG. 9A.

FIG. 9C is a view of a proximal portion of the implant delivery deviceof FIGS. 9A-9B.

FIG. 10 is a perspective view of an actuator arm retainer ring componentof the implant delivery device of FIG. 9A, in accordance with someembodiments.

FIG. 11A is a perspective view of an implant delivery device with anelongate arm in an implant released position that enables the release ofan implant from the elongate arm, in accordance with some embodiments.

FIG. 11B is a perspective view of the implant delivery device of FIG.11A with the elongate arm in an implant clamping position, in accordancewith some embodiments.

FIGS. 12A-12C is a three-part flowchart of an example method forinstalling an implant in a patient to treat a heart condition, inaccordance with some embodiments.

FIGS. 13A and 13B are top and perspective view of a device forfacilitating an open surgical access passageway to the patient's heart,in accordance with some implementations of the method of FIGS. 12A-12C.

FIG. 13C is a perspective view of multiple ones of the device of FIGS.13A and 13B in use on a patient, in accordance with some implementationsof the method of FIGS. 12A-12C.

FIGS. 14A-14C are perspective top and side views of a device formeasuring the size of a heart within the patient, in accordance withsome implementations of the method of FIGS. 12A-12C.

FIG. 15 is a perspective view of the introduction into a patient's chestcavity of an implant that is loaded on an implant delivery device, inaccordance with some implementations of the method of FIGS. 12A-12C.

FIGS. 16A-16C are perspective views of the advancement of an implantonto the patient's heart, in accordance with some implementations of themethod of FIGS. 12A-12C.

FIG. 17 is a perspective view of the withdrawal of an implant deliverydevice after installing an implant on the patient's heart, in accordancewith some implementations of the method of FIGS. 12A-12C.

FIG. 18 is a perspective view of trimming of the implant afterinstalling an implant on the patient's heart, in accordance with someimplementations of the method of FIGS. 12A-12C.

FIG. 19 is a perspective view of another implant for treating a heartincluding three optional bladder locations at the mitral valve, anteriorpapillary muscle, and posterior papillary muscle, in accordance withsome embodiments.

FIG. 20 is a cross-sectional view of an enlarged heart that hasfunctional mitral regurgitation (“FMR”).

FIG. 21 shows the enlarged heart of FIG. 20 with a first inflatedchamber exerting localized pressure on the epicardium near the annulusof the mitral valve.

FIG. 22 shows the enlarged heart of FIGS. 20 and 21 being treated withthe first inflated chamber at the mitral valve annulus and a secondinflated chamber exerting localized pressure on the epicardium near thepapillary muscles.

FIG. 23 is a perspective view of an example fillable bladder thatincludes undulated side walls that allow the bladder to expand withoutdistension of the bladder's material.

FIG. 24 is a cross-sectional view of the fillable bladder of FIG. 23prior to expansion of the bladder.

FIG. 25 is a cross-sectional view of the fillable bladder of FIG. 23after a first stage of expansion of the bladder.

FIG. 26 is a cross-sectional view of the fillable bladder of FIG. 23after first and second stages of expansion of the bladder.

FIG. 27 is a photograph of an expanded fillable bladder with a texturedmaterial on the face of the bladder, in accordance with someimplementations.

FIG. 28 is a perspective side view of an implant for treating a heart,in accordance with some embodiments.

FIG. 29 is a perspective view of a positioning tool with a fillablebladder that includes undulated side walls that allow the bladder toexpand without distension of the bladder's material, in accordance withsome embodiments.

FIG. 30 is a close up perspective view of the fillable bladder of thepositioning tool of FIG. 29.

FIG. 31 is a cross-sectional view of the fillable bladder of FIG. 30prior to expansion of the bladder.

FIG. 32 is a cross-sectional view of the fillable bladder of FIG. 30after a first stage of expansion of the bladder.

FIG. 33 is a cross-sectional view of the fillable bladder of FIG. 30after first and second stages of expansion of the bladder.

FIG. 34 is a flowchart of an example method for using the positioningtool of FIG. 29, in accordance with some embodiments.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring to FIGS. 1A-1B, some embodiments of a system or methoddescribed herein include an implant structure configured to bepositioned around the exterior of an epicardial surface of a heart H.Such an implant 100 can be used, for example, to treat various heartconditions, including but not limited to FMR, tricuspid valveregurgitation, congestive heart failure, or a combination thereof. Forexample, in the embodiment depicted in FIG. 1B, the implant 100 caninclude a fillable bladder 120 coupled to a mesh body 110 at a specificlocation to exert a localized pressure on the posterior lateral surfaceof the heart H to thereby deflect the “P2” portion of the posteriorleaflet of the mitral valve to treat FMR. The combined components of theimplant 100 can be configured to apply supporting or deformation forcesto multiple targeted regions of the heart H in a manner that supportsthe ventricle walls of the heart, particular valve structures of theheart, and (optionally) atrial-ventricular groove of the heart. In use,the implant 100 can be delivered to the heart H through a relativelysmall opening of a selected intercostal space and thereafter expandedover the apex, ventricles, and atrial-ventricular groove of the heart.In some embodiments, a delivery device (described in detail below) canbe operated by a clinician to install the implant 100 on the beatingheart H at a selected location, which is verified in real time by theclinician in real using radiopaque markers positioned at an advantageouscombination of locations along a hem 113 of the leading end, along thefillable bladder 120, or both.

Referring to FIG. 1A, an implant 100 can be positioned around theexternal surface of a heart H (e.g., external to the epicardium) totreat various heart conditions. Such heart conditions can include, butare not limited to, functional mitral regurgitation (“FMR”), tricuspidvalve regurgitation, and congestive heart failure. FMR is a condition inwhich the valve structures are normal but the heart is in an abnormalconfiguration (e.g., an enlarged heart) wherein valve functioning isdegraded or not optimal. The implant 100 in this embodiment has atubular shape that defines an interior space. The implant 100 can beinstalled onto the heart H such that a portion of the heart H ispositioned within the interior space defined by the implant 100. Forexample, in some implementations the implant 100 is installed so thatsome or all of the left and right ventricles of the heart H arepositioned within the interior space defined by the implant 100. In suchan arrangement, the implant 100 surrounds a perimeter of a portion ofthe heart H. Hence, the implants provided herein, of which implant 100is one example, may also be referred to herein as jackets. In thedepicted embodiment, the implant 100 is of a flexible or expandabletubular design in that it has an open distal end 112 and an openproximal end 119. The open distal end 112 of the implant 100 enables theimplant 100 to be implanted by advancing the open distal end 112 aroundthe heart from an inferior (apex) end of the heart to, for example, anatrial-ventricular groove of the heart (described below in connectionwith FIG. 1). The open proximal end 119 of the implant 100 is present inthe depicted embodiment to accommodate a minimally invasive deliverydevice (described below in connection with FIGS. 6A-6C) with one or moremembers that extend through the open proximal end 119 and attach to theopen proximal end 119 of the implant 100 so as to push the distal end112 of the implant 100 over and beyond the apex of the heart H and into,for example, the atrial-ventricular grove, as will be shown anddescribed below.

In some embodiments, the implant 100 can include a tubular mesh body110. The tubular mesh body 110 may include one or more seams 111 thatare formed as a result of the construction of the tubular mesh body 110.For example, the one or more seams 111 may be formed as a result ofmaking the mesh body 110 into a tube, as a result of creating contourswithin the mesh body 110, or as a result of creating hemmed ends of themesh body 110. However, seams are not a requirement in all embodimentsof the implant described herein. That is, in some alternativeembodiments, the implant can be made with a seamless construction.

Still referring to FIG. 1A, a fillable bladder 120 is attached to themesh body 110. The fillable bladder 120 may also be referred to hereinas an inflatable bladder. In this embodiment, the fillable bladder 120is affixed on an interior surface of the mesh body 120. Hence, when theimplant 100 is installed onto the heart H (e.g., between the pericardiumand epicardium), the fillable bladder 120 is positioned adjacent to andmakes contact with the external surface of the heart H. In somealternative embodiments, the fillable bladder 120 can be affixed on theexterior of the mesh body 110, or installed in or between layers ofmaterial of a multi-layered mesh body. In further alternativeembodiments, multiple fillable bladders 120 are affixed on a single meshbody 120.

An inflation tube 130 is in fluid communication with the fillablebladder 120. As described further herein, the inflation tube 130provides a lumen through which an inflation fluid (e.g., saline oranother biocompatible liquid) is transferred to thereby inflate ordeflate the fillable bladder 120. In some embodiments, one or moreligation clips 140 are used to seal the inflation tube 130 after thefillable bladder 120 has been filled with an inflation fluid to adesired extent. As an alternative to the ligation clips 140, theinflation tube 130 can be doubled over to seal the inflation tube 130,and the configuration can be secured by tightly wrapping thedoubled-over portion with a suture. In another alternative, a plug canbe inserted into the end of the inflation tube 130. Other techniques anda combination of techniques can also be used to seal the proximal regionof inflation tube 130. With the one or more ligation clips 140 installedon the inflation tube 130, the selected amount of inflation fluid can bemaintained within the fillable bladder 120. With the fillable bladder120 thusly inflated, the expansion of the bladder 120 causes a localizedpressure to be applied to a selected exterior surface of the heart H(e.g., along an exterior of the epicardium), to thereby treat a heartcondition.

The implant 100 can also include a plurality of radiopaque markers 115and 125 in selected locations that provide a number of benefits to asurgeon during and after implantation. Such radiopaque markers 115 and125 can facilitate radiographical visualization of the implant 100during a minimally invasive implantation process. For example, in someinstances the implant 100 is installed with the assistance offluoroscopy. Other imaging modalities may also be used, such asechocardiography, MRI, and the like. Using imaging systems inconjunction with radiopaque markers 115 and 125, the implant 100 can bepositioned onto the heart H, and oriented in relation to anatomicalfeatures of the heart H, as desired. In some implant procedures,contrast agent solutions are injected into the heart, or within thepericardial space, to enhance the radiographical visualization ofanatomical features of the heart H on which an implant 100 is to beinstalled. The radiopaque markers 115 and 125 can comprise materialssuch as, but not limited to, tantalum, platinum, tungsten, palladiumalloys, and the like.

In the embodiment shown, a first group of radiopaque markers 115 arepositioned at a leading end 112 of the mesh body 110. The leading end112 in this embodiment includes a circumferential hem region thatdefines the distal end opening 117 (refer to FIG. 2A). As describedfurther herein, in some embodiments the radiopaque markers 115 are usedto facilitate the installation of the implant 100 in relation to theheart H such that the leading end 112 is positioned in theatrial-ventricular groove of the heart H. A second group of radiopaquemarkers 125 are positioned on the implant 100 to identify the locationof the fillable bladder 120 on the mesh body 110. For example, thesecond group of markers 125 can be mounted along at least a portion of aperiphery of the fillable bladder 120. Using the radiopaque markers 125,the fillable bladder 120 can be positioned at a target location on theexterior surface of the heart H. For example, as will be describedfurther herein, in some instances the fillable bladder 120 may beconfigured for installation at a selected position on the surface of theheart H (for example, on a posterior wall of the heart adjacent themitral valve) so that the fillable bladder 120 will exert a localizedpressure to induce the reshaping of a portion of the heart H when thefillable bladder 120 is inflated. In the case of positioning on aposterior wall of the heart adjacent the mitral valve, the fillablebladder 120 provides localized pressure that in turn is applied to aposterior portion of the mitral valve annulus, thus bringing theleaflets of the valve into closer proximity with one another andaddressing a mitral valve regurgitation problem (described, for example,in more detail below in connection with FIG. 1B). While this embodimentincludes the radiopaque markers 115 and 125 located near the leading end112 and fillable bladder 120 respectively, in other embodimentsradiopaque markers may be included at other locations instead of, or inaddition to, the locations of the radiopaque markers 115 and 125.

Still referring to FIG. 1A, the mesh body 110 of the implant 100 alsoincludes a trailing end portion 118 that is located opposite of theleading end 112. The trailing end portion 118 may also be referred toherein as the proximal region. The trailing end portion 118 can providethe implant 100 with an axial length such that, when the implant 100 isinstalled on the heart H, excess mesh material extends proximally awayfrom the apex A of the heart H. As described in detail below, afterinstalling the implant 100 onto the heart H, an excess length portion ofthe trailing end portion 118 can be optionally trimmed off of theimplant 100. Thereafter, in some implementations the trimmed end of themesh body 110 at the trailing end portion 118 is gathered or cinchedaround the apex A and closed using one or more sutures, clips, or thelike. This implementation of providing a post-installation closure tothe trimmed end of the mesh body 120 may be preferred in some cases, forexample, to prevent the proximal end of the implant 100 from migrating,after implantation, distally toward the distal end of the implant 100,which may otherwise occur given the movement of the heart and the lesserdegree anchoring of the implant 100 immediately after installation(before fibrosis and tissue ingrowth between the implant 100 and theheart tissue such as the epicardium, pericardium, or both).

Referring now to FIG. 1B, the implant 100 can be installed on the heartH so as to surround an inferior portion of the heart H, including atleast a portion of the left and right ventricles V. In some embodiments,at least a portion of the leading end 112 is positioned in theatrial-ventricular groove of the heart H. By positioning the leading end112 in the atrial-ventricular groove AV, the implant 100 can maintain adesired positioning in relation to the heart H by taking advantage ofthe contours of the heart H. In this embodiment, the implant 100 isinstalled in the pericardial cavity. That is, during the implantationprocess, the pericardium is opened and the implant 100 is installed overan exterior of the epicardium of the heart H and internal to thepericardium of the heart H. Thereafter, the pericardium is closed tothereby contain the implant 100 in the pericardial cavity. Over time, afibrosis or tissue ingrowth process may occur to cause the mesh body 110to be anchored to the epicardium, the pericardium, or a combinationthereof. Optionally, in some instances, one or more sutures may be usedto attach the mesh body 110 to the epicardium at the time ofimplantation.

In the depicted embodiment, the fillable bladder 120 is attached to aninterior surface of the mesh body 110 such that, when the implant 100 isimplanted, the fillable bladder 120 is positioned between the mesh body110 and the heart H. In other words, a surface of the fillable bladder120 is in direct contact with a surface of the heart H (e.g., anexterior epicardial surface in this embodiment). When an inflation fluidis supplied under pressure into the fillable bladder 120 (e.g., from asyringe device coupled to the inflation tube 130), the fillable bladder120 expands from a collapsed condition to an operative condition tothereby exert a localized pressure to a targeted portion of the surfaceof the heart H. A target location for applying the localized pressurecan be strategically selected to induce a desired effect to thepatient's heart H. For example, as shown, a localized pressure can beexerted at a location on the heart H that causes a deflection to anannulus of a heart valve HV, such as a mitral valve or a tricuspidvalve. In that manner, some types of valvular regurgitation can betreated. In a particular example, the fillable bladder 120 can bepositioned to exert a localized pressure on the posterior lateralsurface of the heart H to thereby deflect the “P2” portion of theposterior leaflet of the mitral valve to treat FMR. In another example,other areas on the exterior surface of the ventricles V can be targetedfor the exertion of a localized pressure from the fillable bladder 120.In some such examples, the papillary muscles P are advantageouslydeflected. In certain instances, such deflecting of the papillarymuscles P, and the chordae tendineae CT confluent therewith, can alsotreat valvular regurgitation.

While the examples of FIGS. 1A and 1B depict an implant 100 having asingle fillable bladder 120, it should be understood that in otherembodiments two or more fillable bladders may be included on a singleimplant device. In the depicted embodiment, the fillable bladder 120 ispre-attached to the mesh body 110. In some embodiments, one or morefillable bladders are separate from the mesh body, and are attached tothe mesh body or positioned at a desired location inside the mesh bodyduring the implantation procedure either before or after the mesh bodyhas been installed on the heart. For example, the mesh body may beinstalled on the heart H of a patient, and subsequently one or morefillable bladders can be positioned at target locations in relation tothe mesh body and then optionally attached to the mesh body in situ.

In some embodiments, the mesh body 110 is sized to snugly fit on theheart H, but not so tight as to cause a significant increase in leftventricular pressure during diastole or obstructions to the coronaryarteries or other vessels such as the coronary sinus. That is, in theseembodiments, the mesh body 110 is designed to be highly compliant to theshape of the heart H, and adaptable to gently conform with thedistension of the myocardium as the heart H performs pumping actions.

Referring to FIGS. 2A-2C, the implant 100 of FIG. 1 will now bedescribed in greater detail. FIG. 2A provides a perspective viewillustrating the tubular shape and other features of the implant 100.FIGS. 2B and 2C provide end perspective views to illustrate, forexample, the interior surfaces of the implant 100 and the fillablebladder 120. For instance, FIG. 2B depicts the fillable bladder 120 in adeflated configuration, while FIG. 2C depicts the fillable bladder 120in an inflated configuration.

In some embodiments, the material of the mesh body 110 is constructedfrom a knitted, biocompatible material. In particular embodiments, theknitted material is made using a construction known as “Atlas knit.” TheAtlas knit is a knit of fibers having directional expansion properties.More specifically, the knit, although formed of generally inelasticfibers, permits a construction of a flexible fabric at least slightlyexpandable beyond a rest state. The fibers of the mesh fabric are woveninto two sets of fiber strands. The strands are interwoven to form thefabric with a first set of strands generally parallel and spaced-apartand with a second set of strands generally parallel and spaced-apart.For purposes of illustration in FIGS. 2A-2C, the mesh fabric isschematically shown herein as a diamond-shaped open cell mesh fabrichaving diagonal axes, but it should be understood from the descriptionherein that the mesh fabric may have a different appearance. FIGS. 1Aand 2A illustrates the knit mesh body 110 in a generally unexpandedstate, whereas FIG. 1B illustrates the knit mesh body 110 is an expandedstate. In some embodiments, the mesh body 110 is made of a Denierpolyester. In other embodiments, the mesh body 110 can be made of othersuitable biocompatible materials including polytetrafluoroethylene(PTFE), expanded PTFE (ePTFE), polypropylene, stainless steel, and thelike, or combinations thereof. Other types of knitting processes canalso be used to construct the implants provided herein. Further, otherconstruction techniques in addition to knitting are envisioned. Forexample, some or all parts of the body 110 may be woven, braided, madeof tubing or an expanded tubing, and the like.

In some embodiments, the mesh body 110 includes a leading end portion114, a transition portion 116, and a trailing end portion 118. Each ofthe three portions 114, 116, and 118 are tubular. That is, the meshmaterial used to construct the portions 114, 116, and 118 is arranged todefine open interior spaces. In this embodiment, the mesh body 110 isconfigured to provide a cross-section shape (e.g., perpendicular to acentral axis of the implant 100) that is circular in each of the threeportions 114, 116, and 118, and the portions 114 and 118 may begenerally cylindrical along a majority of their respective axiallengths. In other embodiments, the materials can be arranged to defineother cross-sectional shapes. In other embodiments, other configurationsof implant body shapes are envisioned, and such portions 114, 116, and118 are not necessarily implemented in all embodiments described herein.In some embodiments, the construction of the mesh body 110 may includeone or more seams 111 as a result of sewing the mesh material into thedesired shape. In some embodiments, the construction of the mesh body110 may be seamless.

Still referring to FIGS. 2A-2C, in this embodiment, the generallycylindrical leading end portion 114 provides the largest diameter of thethree portions 114, 116, and 118 (when the implant 100 is in anon-stressed state prior to implantation). In some embodiments, thethree portions 114, 116, and 118 are not separately constructed regions,but rather are defined regions of a device constructed from a singlepiece of mesh material. In other embodiments, the three portions 114,116, and 118 may be separately constructed and attached together to formthe final implant construction. The trailing end portion 118 providesthe smallest diameter of the three portions 114, 116, and 118 (when theimplant 100 is in a non-stressed state prior to implantation). Thetransition portion 116 extends between a proximal end periphery of theleading end portion 114 and a distal end periphery of the trailing endportion 118. The transition portion 116 has diameter variance from itsdistal end portion to its proximal end portion. That is, the transitionportion 116 may be tapered (providing either a linear taper or a curvedtaper), extending proximally from the leading end portion 114 whiledecreasing in diameter to join with the distal end periphery of thetrailing end portion 118. In some embodiments, the transition portion116 comprises a frustoconical shape. In particular embodiments, some orall of the transitional region 116 has a radiused profile to providesmooth transitions to the leading and trailing portions 114 and 118.

In some embodiments, at least a portion of the leading end portion 114has a diameter and construction for positioning around a heart in theatrial-ventricular groove AV of the heart H. For example, a hem 113comprising an elastic band member may be configured for positioningaround an atrial-ventricular groove AV (refer to FIG. 1), to therebyreleasably affix the leading end 112 to the heart H. The diameter of thehem 113 (including the elastic band member) may be selected in relationto the size of the heart of a patient. The selected diameter of the hem113, at rest, will be smaller than the perimeter of the heart at theatrial-ventricular groove, to provide an interference fit therebetween.The high compliance and elasticity of the hem 113 (including the elasticband member) facilitates an interference fit that is effective formaintaining the implant 100 in the targeted position on the heart Hwhile not detrimentally constricting the heart and vessels on theoutside of the heart such as the coronary artery or coronary sinus overwhich the hem 113 may be positioned when the implant 100 is implanted.

Portions of the leading end portion 114, other than the hem 113, areconfigured for circumferentially encompassing upper portions of theheart ventricles. In addition, some or all of the transition portion 116may be configured for circumferentially encompassing other portions theheart ventricles. Most or all of the trailing end portion 118 may beconfigured to extend proximally from the apex of the heart when theleading end 112 is positioned in the atrial-ventricular groove. Afterinstallation of the implant 100 on a heart, some or all of the trailingend portion 118 may be trimmed away and removed from the implant 100.Thereafter the trimmed proximal end of the implant 110 may gathered orcinched and closed around the apex of the heart. Closing the proximalopen end prevents the implant 100 from migrating toward the superiorregions of the heart after implantation. In this manner, the implant 100can be tailored to fit the patient-specific size and contours of theheart on which the implant 100 is installed.

Multiple sizes of implants 100 are envisioned that are suitable fortreating multiple sizes of hearts. For example, the diameters of some orall of portions 114, 116, and 118 can be available in incremental sizes.In some embodiments, the axial lengths of some or all of portions 114,116, and 118 are also configured in incremental sizes. As will bedescribed further herein, an implant 100 of a particular size can beselected for a patient based on a pre-operative measurement of thepatient's heart. For example, in some instances a measurement is takenof the patient's largest ventricular perimeter, and that measurement isused to select the size of implant 100 to be used for that patient. Aswill be described further herein, various sizes of implants 100, each ofwhich is preloaded on an implant delivery device (refer to FIGS. 5-7),can be available to a clinician, and the clinician can select aparticular size of implant 100 based on the measurement of the patient'sheart. In some embodiments, a particular size of implant 100 can be usedfor a range of heart measurement values. For example, a particular sizeof implant 100 may be used for a range of maximum ventricular perimetersof 36.9 cm to 40.0 cm. Another size of implant 100 may be used for arange of maximum ventricular perimeters of 40.1 cm to 43.4 cm. Stillanother size of implant 100 may be used for a range of maximumventricular perimeters of 34.0 cm to 36.8 cm, and so on. It should beunderstood that these ranges of maximum ventricular perimeters providedare merely illustrative, and are non-limiting examples. In addition, thecombination of mesh material compliance and size, hem constructionincluding the compliance of an elastic band on the hem 113, and fillablebladder construction include the compliance of materials used toconstruct together may be selected in accordance with the teachingsherein to achieve implant design configurations that enable a fewernumber of sizes for a wide range of heart sizes, thereby achievinginventory cost benefits. In some embodiments, the trailing end portion118 is configured to have the same diameter across all sizes ofimplants. The fillable bladder 120 may also be implemented with varioussizes. For example, larger fillable bladders may be used with largersized implants, and smaller fillable bladders may be used with smallersized implants.

Still referring to FIGS. 2A-2C, the leading end 112 in this embodimentis defined by the hem 113. In some embodiments, the hem 113 can beconstructed by wrapping some of the mesh material at the distal end ofthe leading portion 114 around the elastic band, and then securing thefree end of the material to an interior portion of the leading endportion 114. Such securing may be continuous or in multiple discreetsections. In particular embodiments an elastic hem band material can becontained within the doubled over layers of mesh material. The elastichem band material can be made of a low durometer silicon elastomermaterial, or any other suitable elastic biocompatible material. Thediameter of the elastic hem band material, at rest, may be less than theat rest diameter of the mesh material at the hem 113. By way of example,in some embodiments the circumference of the mesh material, at rest, inthe hem 113 may be about 25 centimeters, whereas the length of theelastic hem band material may be about 20 centimeters. Such aconfiguration may accommodate, by way of example only, a heart sizewherein the atrial-ventricular groove may be about 30 centimeters incircumference. Owing to the length of the elastic band being longer thanthe circumference of the mesh material at the hem 113, the mesh materialat the hem 113 may be gathered in a slightly wavy or “bunched”configuration about the internal elastic member when the hem 113 is notbeing stretched around the heart H. In some alternative embodiments, theinternal elastic band may not be implemented, and in such cases, themesh material may be configured into a reduced diameter region in thehem area so as to enable an interference fit of the hem area into anatrial-ventricular groove. In other alternative embodiments, the elasticband serve as the hem 113 and distal end 112 with the mesh materialwrapping around it, and in such cases, the mesh material may be bondedto a proximal periphery of the elastic band. Optionally, the trailingend 119 may also be hemmed, and the hem of the trailing end 119 may ormay not include an elastic member.

As previously described, some embodiments of the implant 100 includemultiple radiopaque markers 115 located around the hem 113 and multipleradiopaque markers 125 located around the periphery of the fillablebladder 120. As described previously, various types of radiopaquemarkers can be used. In some embodiments, the radiopaque markers 115 and125 have an adhesive quality during manufacture of the implant 100 thatcan be used advantageously during the construction of the implant 100.For example, the second group of radiopaque markers 125 can be adheredto the mesh body 110 and, via the interstitial spaces of the mesh,adhered to the fillable bladder 120 to thereby affix the fillablebladder 120 to the implant 100. In one such embodiment, the radiopaquemarkers 125 (and 115) can be made from raw materials such as a siliconeadhesive paste mixed with powdered tantalum. During manufacturing of theimplant 100, the mixture can be injected into depressions residing in ametal plate, and that are configured in a generally rectangular patternas defined by the radiopaque markers 125 shown in the implant 100. Themetal plate can thereby act as a mold for forming the radiopaque markers125. The mesh body 110 can be placed over the metal plate in anorientation that will position the fillable bladder 120 as desired inrelation to the mesh body 110. The fillable bladder 120 can be placed ontop of the mesh body 110 in an orientation so as to locate theradiopaque markers 125 around the periphery of the fillable bladder 120.A second metal plate can be positioned over the fillable bladder 120.The second metal plate may have a depression that corresponds to thefillable bladder 120. The stacked assembly can then be heated to curethe silicone adhesive paste. In the process, the radiopaque markers 125become adhered to the mesh body 110 and to the fillable bladder 120. Inthis manner, the radiopaque markers 125 can be used to affix thefillable bladder 120 to the mesh body 110. Using a similar technique,the radiopaque markers 115 can be formed and adhered to the exteriorlayer of the mesh material of the hem 113, and adhered to the internalelastic band of the hem 113. Furthermore, the elastic band can therebybe “staked” in relation to mesh material of the hem 113 at the locationsof the radiopaque markers 115. In other embodiments, the fillablebladder 120 and/or elastic band of the hem 113 can be affixed to themesh body 110 using other bonding techniques, such as adhesives,mechanical clips, sutures, interweaving, ultrasonic welding, RF welding,and the like.

Still referring to FIGS. 2A-2C, the implant 100 includes the fillablebladder 120, which as previously described, can be used to exert alocalized pressure on a surface of the heart to induce a therapeuticdeflection thereto. FIG. 2B illustrates the fillable bladder 120 in adeflated state, and FIG. 2C illustrates the fillable bladder 120 in aninflated state. While the fillable bladder 120 depicted in FIGS. 2A-2Cis generally rectangular in shape, other shapes of fillable bladders arealso envisioned. For example, fillable bladders can be circular,elliptical, semi-toroidal, triangular, linear, pyramidal, irregularlyshaped, and any other like shape, or combinations of shapes.

As previously described, the inflation tube 130 is in fluidcommunication the fillable bladder 120. The inflation tube 130 is of aflexible tubular construction and is configured to remain in thepatient's body as part of the implant 100, and to remain in fluidcommunication with the fillable bladder 120. The free end of theinflation tube 130 can be positioned subcutaneously, and near to theunderside of the epidermis. In some implementations, the free end of theinflation tube 130 is located in an intercostal space after implantationof the mesh body 110 around the heart. So locating the free end of theinflation tube 130 may allow future access to the inflation tube 130 viaa simple cut-down procedure through the skin adjacent to the intercostalspace between the ribs (e.g., the fifth intercostal space in someimplementations). Future inflation or deflation of the fillable bladder120 may thereby be performed with a minimally invasive access to anintercostal space under the side without extensive surgery to access thepericardium or epicardium.

In some embodiments, the flexible inflation tube 130 is made ofsilicone, but other biocompatible materials may also be used. In someembodiments, the outer diameter of the inflation tube 130 can range fromabout 0.065 inches to about 0.25 inches (about 1.60 mm to about 6.40mm). In one example embodiment, the outer diameter of the inflation tubeis about 0.125 inches (about 3.2 mm). In some embodiments, the innerdiameter of the inflation tube 130 can range from about 0.031 inches toabout 0.125 inches (about 0.78 mm to about 3.18 mm). In one exampleembodiment wherein the outer diameter of the inflation tube is about0.125 inches (about 3.2 mm), the inner diameter of the inflation tube isabout 0.0625 inches (about 1.58 mm). Such inflation tube dimensions areprovided as examples, and it should be understood that other sizes arealso envisioned within the scope of this disclosure. In addition, thecross-sectional sizing of the inflation tube may be selected toaccommodate the specific inflation material (and in some casesradiopaque contrast agent) that will flow through the tube (discussedbelow).

The inflation tube 130 provides a flexible conduit through whichinflation fluid can be conveyed to inflate or deflate the fillablebladder 120. After inflating or deflating the fillable bladder 120 witha selected volume of inflation fluid, the proximal end region of theinflation tube 130 is sealed to prevent withdrawal of the inflationfluid from the fillable bladder 120. Various types of inflation fluidscan be used. For example, the inflation fluid can be a saline liquidsolution, silicone gel, gaseous substances, and fluids containing acontrast agent that facilitate visualization of the inflation fluid viaimaging systems.

In some embodiments, the fillable bladder 120 is configured of twodifferent sheet components 122 and 124 so that the bladder 120, wheninflated, expands more interiorly (that is, toward the heart wall whenimplanted) than exteriorly. As such, the bladder 120 is configured toprovide a differential compliance in which one surface of a bladder 120is significantly more compliant than the opposing (less compliant)surface of the bladder 120. In the context of fillable bladder 120, theinterior sheet component 122 of the fillable bladder 120 is morecompliant than the outer sheet component 124 of the fillable bladder120. When the implant 100 is installed on a heart, the heart is locatedwithin the interior region of the mesh body 110 and in contact with theinterior sheet component 122 of the fillable bladder 120. The greatercompliance of the interior sheet component 122 of the fillable bladder120 (in relation to the lesser compliance of the outer surface material)can accentuate the localized pressure applied onto the surface of theheart when the fillable bladder 120 is inflated.

Referring now to FIG. 3, some embodiments of the fillable bladder 120can include the two different sheet components 122 and 124 in the formof an interior sheet component 122 and an outer sheet component 124. Achamber for containing fluids can be formed therebetween by hermeticallysealing together the periphery of the sheet components 122 and 124. Asdiscussed above, this sealed periphery of the bladder 120 is the portionof the bladder 120 to which the radiopaque markers 115 are attachedthrough spaces in the mesh material interposed between the bladder 120and the markers 115. In this embodiment of the bladder 120 shown in FIG.3, the sheet components 122 and 124 are sealed together using a bondingagent 126, but other techniques are also envisioned, such as ultrasonicwelding, solvent bonding, a molded monolithic bladder, and the like. Anend portion of the inflation tube 130 is also sealed between the sheetcomponents 122 and 124, such that the lumen of the inflation tube 130 isin fluid communication with the resulting chamber of the fillablebladder 120. In some embodiments, a fitting may be used to couple aninflation tube to a fillable bladder.

The material of the interior sheet component 122 can be selected to havea higher compliance than the material selected for the outer sheetcomponent 124. The interior sheet component 122 can be made of asilicone sheet material, or other biocompatible airtight sheetmaterials. In some embodiments, the thickness of the interior sheetcomponent 122 is in the range of about 0.005 inches to about 0.050inches (about 0.12 mm to about 1.30 mm). In one example embodiment, theinterior sheet component 122 is a silicone sheet material that is about0.015 inches (about 0.38 mm) in thickness. The outer sheet component 124can also be made of a silicone sheet material, or other biocompatibleairtight sheet materials. In some embodiments, the material of the outersheet component 124 can be reinforced (e.g., with a polyester mesh thatis impregnated into the sheet) to resist deformation, thereby reducingthe compliance of the outer sheet component 124. In some embodiments,the thickness of the outer sheet component 124 is in the range of about0.005 inches to about 0.070 inches (about 0.12 mm to about 1.78 mm). Inone example embodiment wherein the interior sheet component 122 is asilicone sheet material that is about 0.015 inches (about 0.38 mm) inthickness, the outer sheet component 124 is a reinforced silicone sheetmaterial that is about 0.020 inches (about 0.51 mm) in thickness.

Various sizes of inflatable bladders 120 can be constructed, anddifferently sized inflatable bladders 120 can be used with differentlysized implants. In some embodiments, the length and width dimensions ofthe sheet components 122 and 124 (including the peripheral regions ofthe membranes that are sealed together) can be in a range from about 0.5inches to about 4.0 inches (about 12.7 mm to about 101.6 mm). In oneexample embodiment, the length and width dimensions of the membranes 122and 124 are in a range from about 1.075 inches to about 2.265 inches(about 27.30 mm to about 57.53 mm). In some embodiments, the fillablebladder 120 has a peripheral seal that is about 0.25 inches (about 6.35mm) wide, and the sheet material within the peripheral seal is theinflatable portion.

In this embodiment, the peripheral bonding of the sheet components 122and 124 can be accomplished using the bonding agent 126. The bondingagent 126 can cross-link with the materials of the sheet components 122and 124 when the bonding agent 126 and sheet components 122 and 124 areheat-soaked as an assembly. In one example, the assembly is heat-soakedat about 350 F (about 177 C) for about 2 hours. Other heat-soaking timeand temperature combinations can also be used, and lower temperatureswill tend to require longer durations (and vice versa). Various types ofbonding agents 126 can be used. In a preferred embodiment, the bondingagent 126 is a non-vulcanized silicone sheet that is about 0.010 inches(about 0.25 mm) thick. After the bonding of the inner and sheetcomponents 122 and 124, and the inflation tube 130, the fillable bladder120 can be leak tested to confirm that the fillable bladder 120 ishermetically sealed.

Upon implantation and proper positioning of the fillable bladder 120with respect to targeted heart H structure(s), the fillable bladder 120(and specifically the bladder's interior sheet component 122) is locatedand bears against an outer epicardial wall of the heart H, and the meshmaterial of the mesh body 110 that is located exteriorly of the bladder120 faces outwardly and bears against the pericardium. When the bladder120 is inflated, the interior sheet component 122 of the bladder 120expands inwardly (e.g., expansion from a reference plane defined asextending through the sealed periphery region of the bladder 120) moreso than the outer sheet component 124 of the bladder 120 expandsoutwardly from this reference plane. This characteristic is accentuatedin larger bladder embodiments in comparison to smaller bladderembodiments. Therefore, design selections, including interior and outersheet properties as well as bladder size and other parameters, can bemade to attain a fillable bladder with the desired expansioncharacteristics.

The combination of the implant's mesh body 110 located exteriorly of thebladder 120 (which provides an circumferential restraint force to urgethe bladder 120 toward the heart H) and the presence of the pericardiumthat surrounds the heart H (the pericardium providing a bearing surfaceagainst which the implant's mesh material and hence the outer sheetcomponent 124 of the bladder 120 bears) collectively resist outwardmovement of the bladder 120. This resistance to outward movement of thebladder 120 from the heart H also contributes so that the interior sheetcomponent 122 of the bladder provides localized pressure upon thetargeted surface region of the heart. This localized pressure deformsnot only the targeted surface region of the heart wall, but also valvestructures located inside the chambers of the heart in the location ofthe localized pressure (refer to FIG. 1). In addition, at some point intime after implantation (typically in about 1 week to 3 weeks), the meshbody 110 makes a fibrous attachment to both the epicardial wall and tothe pericardium. This fibrous attachment of the mesh body 110 to boththe epicardial wall and the inner wall of the pericardium increases theresistance to outward movement of the bladder 120, thereby increasingthe degree to which the inward expansion of the interior sheet component122 of the bladder 120 provides localized pressure upon the targetedsurface region of the epicardial wall that lies adjacent the bladder120.

FIGS. 4A and 4B show alternative embodiments having one or moreinflatable bladders, as follows. In FIG. 4A, the inflatable bladder ispositioned adjacent to the patient's mitral valve. FIG. 4B showsadditional placement locations of bladders adjacent to the papillarymuscle and tricuspid valve. It is to be understood that the descriptionherein encompasses embodiments with only one or with more than oneinflatable bladder. Thus, FIGS. 4A and 4B simply show preferredlocations for the bladder placement(s).

As seen in FIGS. 4A-B and 5, the depicted embodiment provides anassembly making up an implant 1 wherein the assembly comprises: a jacket10 and at least one inflatable bladder 20. Jacket 10 is made of aflexible biocompatible material and has an open top end 12 that isreceived around the heart H and a bottom portion 14 that is receivedaround the apex A of the heart. In optional aspects, jacket 10 may bemade of a knit mesh. This knit mesh may optionally be made of a polymer,including but not limited to high-density polyethylene. Alternatively,jacket 10 may be made of metal.

In one example embodiment, jacket 10 is made of a suitable knitmaterial. An example of such a knit material may be “Atlas Knit”material described above. Alternatively, jacket 10 may be elastic.Optionally, the fibers may be made of Denier polyester. However, othersuitable materials, including but not limited to, PTFE, ePTFE,polypropylene and stainless steel may also be used. Advantages of usinga knit material include flexibility, fluid permeability and minimizingthe amount of heart surface area in direct contact with the jacket(thereby minimizing the potential of scar tissue development).

Inflatable bladder 20 is disposed on an interior surface of jacket 10.Bladder 20 may or may not be attached to jacket 10. FIG. 4B illustratesthree separate inflatable bladders 20, one being located near a hem ofthe implant 1 and being positioned on a posterior portion of the heart Hwall adjacent the mitral valve (bladder 20A), one being located awayfrom the hem for positioning to a portion of the heart H wall adjacentto a papillary muscle (bladder 20B), and one being located also near ahem of the implant 1 and positioned on an anterior portion of the heartH wall adjacent the tricuspid valve (bladder 20C). In embodimentswherein the bladder 20 is attached to the jacket 10 prior toimplantation of the implant 1, the implant may include one, two or allof the three bladders 20A-C depicted in FIG. 4B. As such, FIG. 4Bdepicts the different locations where a bladder 20 may be located,wherein some embodiments may include only one or two bladders 20positioned on the jack 10 so that the bladder 10 may be positioned atthe depicted locations shown in FIG. 4B. When bladder 20 (that is,bladder 20A in FIG. 4B) is positioned adjacent to the mitral valve, itis preferably positioned at the P2 area of the valve (in the center ofthe posterior leaflet) to reduce the distance across the valve, therebyreducing the gap in the valve responsible for the regurgitation. Whenbladder 20C is positioned adjacent to the tricuspid valve, it performs asimilar function, reducing regurgitation through the tricuspid valve.When bladder 20B is positioned adjacent to the papillary muscle, itgently corrects papillary muscle position and relieves tension on thechordae (which otherwise prohibits normal valve functioning).

As seen in FIG. 5, inflatable bladder 20 has an inelastic outer surface22 positioned adjacent to jacket 10 and an elastic inner surface 24positioned adjacent to the heart H, as discussed previously inconnection with other embodiments. Bladder 20 may optionally be made ofsilicon. In some embodiments, jacket 10 is relatively non-compliant incomparison to the elastic inner surface 24, the outer surface 22 ofbladder 20 positioned adjacent to the bladder is also relativelynon-complaint, and the inner surface 24 of bladder 10 is elastic. As aresult and as described above, when inflated through fluid supply line25, inflation of bladder 20 causes the bladder to deform substantiallyinwardly (i.e.: towards the heart). This then exerts localized pressureagainst a region of the heart. As can be seen, supply line(s) 25 arepositioned inside jacket 10 and extend out of an open bottom end 13 ofthe jacket adjacent to the apex of the heart. Bottom end 13 may becinched (and/or sewn) closed after the jacket 10 has been positionedaround the heart.

As discussed previously, bladder 20 may be inflated with fluidsincluding air, inert gasses (such as fluorocarbons), silicone gel,saline and contrast agents. Supply lines 25 may optionally be inflatedthrough a blunt needle port, a Luer port fitting, a subcutaneous port26, etc. In other embodiments, a port-type device may not be used, andinstead, the supply lines may be clamped in a closed position, asdescribed previously. Supply lines 25 are made of a suitablebio-compatible material, including but not limited to silicone. Thisdocument includes a disclosure of various mechanisms for inflating anddeflating bladders 20 post-implementation. For example, in one approachthe device is first received onto the heart. After a period of time(e.g.: 30 days) fibrotic encapsulation of mesh jacket 10 will haveoccurred. At this time, the bladder(s) 20 can then be inflated (throughsupply line 25 using a needle to percutaneously access filling reservoir26). Thus, subcutaneous ports 26 may be employed for percutaneousinflation and deflation for therapy optimization or abandonment.Alternatively, and because in some cases implanted subcutaneousport-type devices may have potential drawbacks, clamping of the fluidpath tube may be done, with the fluid path staying in the intercostalspace and may be accessed by a small “cut-down” procedure to access thetube.

In optional embodiments, jacket 10 has an elastic band 14 passing aroundits top end 12, as described previously. In addition, radiopaque markers15 can also be provided around top end 12 of the implant 1.

The present jacket and bladder implant system 1 can be placed around thepatient's heart in a variety of different approaches. In an examplemethod of use, the present system further includes a delivery device forpositioning the jacket onto the heart, as described later in thisdocument. In one example of the method described later in this document,the assembly is implanted into the patient in a left intercostalmini-thoracotomy using contrast pericardiography and fluoroscopicvisualization. After opening the parietal pericardium, the lower portionof the heart is free for applying the jacket over the apex.

In some embodiments, methods of providing localized pressure to a regionof a patient's heart H to improve heart functioning may be performed by:(a) positioning an assembly around a patient's heart, wherein theassembly comprises a jacket 10 and at least one inflatable bladder 20,wherein jacket 10 is made of a flexible biocompatible material having anopen top end 12 that is received around the heart and a bottom portion14 that is received around the apex of the heart, and the inflatablebladder 20 is disposed on an interior surface of the jacket, and theinflatable bladder 20 has an inelastic outer surface positioned adjacentto the jacket and an elastic inner surface. In addition, bladder 20 maybe inflated causing it to expand such that the bladder deformssubstantially inwardly to exert localized pressure against a region ofthe heart.

In another method of use, a pericardial edge management system (PEMS)may be used in the surgical procedure for safe introduction of theimplant 1. A PEMS includes multiple separate sheets that each have one“peel and stick” side, and may be made of Teflon. These sheets can beused to keep the opening into the pericardium open to facilitateinsertion of the device without damage to the pericardium (i.e., theinsertion tool getting hung up on the edges of the opening). Inaddition, the PEMS can be used to initially separate the heart from themesh fabric. After all of the PEMS sheets are pulled out, the jacketfabric can then engage the heart.

Referring to FIGS. 6A-6C, some embodiments of a delivery device 200 canbe used by a clinician to install the implant 100 onto a patient'sheart. As described in detail below, during a procedure to install theimplant 100, some distal portions of the delivery device 100 aretemporarily advanced within the body of the patient, while otherproximal portions of the delivery device 100 remain external to thepatient's body. The delivery device 200 used for installing the implant100 is a sterile device. In some embodiments, the delivery device 200 isa sterile single-use device. Alternatively, the delivery devices may bedesigned to be re-sterilized and reused.

In this embodiment, the implant 100 is loaded onto the delivery device200 at a distal end of the delivery device 200. A main body 210 of thedelivery device 200 is located near a proximal end of the deliverydevice 200. A barrel assembly 220 extends from the main body 210 to thedistal end of the delivery device 200. The implant 100 surrounds and iscoupled to a distal end of the barrel assembly 220. A proximal end ofthe barrel assembly 220 is attached to the main body 210. A heartstabilizer assembly 230, which may be configured to releasably anchor tothe apex of the hearth H during an implantation procedure, extends froma proximal end of the main body 210 to the distal end of the barrelassembly 220.

In some embodiments, the delivery device 200 and the implant 100 arepre-assembled and packaged together in sterile packaging. That is, thedelivery device 200 can be provided to a clinician with the implant 100pre-loaded onto the delivery device 200 and ready for sterile use. Asdescribed elsewhere herein, implants 100 of various sizes are used inorder to properly fit multiple sizes of hearts. Therefore, a hospitalthat performs procedures to install the implants 100 may keep aninventory of various sized implants 100, each of which is pre-loaded ona particular delivery device 200 and packaged in sterile packaging.After the clinician determines the size of patient's heart, theclinician can select from the hospital's inventory the implant 100 thatis sized to best fit the patient's heart. The clinician will receive asterile delivery device 200 that is pre-loaded with that selected sizeof implant 100. After the implant 100 is deployed from the deliverydevice 200, the delivery device 200 may be discarded as a single-useinstrument (for those embodiments in which the delivery device 200 ispackaged as a single-use device).

Still referring to FIGS. 6A-6C, the main body 210 of the delivery device200 may optionally include a pistol grip type handle 212 for handling bya clinician and also may include a lock release button 214 for the heartstabilizer 230. The pistol grip handle 212 provides a convenient andergonomic structure by which a clinician can grasp and maneuver thedelivery device 200. In some embodiments, the pistol grip handle 212includes a textured surface to enhance the friction between the pistolgrip handle 212 and the clinician's hand. The lock release button 214 inthis embodiment is a spring-loaded depressible button that is biased toextend outward from the main body 210. When the lock release button 214is depressed inward in relation to the main body 210, the heartstabilizer assembly 230 is unlocked and therefore able to translateaxially relative to the pistol grip type handle 212. When the lockrelease button 214 is not depressed, the lock release button 214 extendsoutward from the main body 210 and the heart stabilizer assembly 230 islocked in its axial position and therefore not able to translateaxially.

The barrel assembly 220 of the delivery device 200 may optionallyinclude a splined elongate barrel 222 for guiding the actuators 224 ofthe delivery device 200. In this embodiment, six actuators 224 areincluded around the periphery of the barrel 222. In other embodiments,fewer or more than six actuators can be included in a delivery device.The actuators 224 are each individually slidably coupled to a spline ofthe barrel 222. The actuators 224 are also each individually releasablycoupled to an epicardial management strip 250. In this embodiment, thereare a total of six epicardial management strips 250. The epicardialmanagement strips 250 extend from the actuators 224, on the externalsurface of the barrel 222, under the implant 100, and terminate wherethe implant 100 is coupled to the delivery device 200. The epicardialmanagement strips 250 provide low-friction surface area that facilitatesthe advancement of the implant 100 onto a heart. The epicardialmanagement strips 250 are not shown in FIG. 6C so that other componentsof the implant 100 and delivery device 200 are visible.

Still referring to FIGS. 6A-6C, the heart stabilizer assembly 230 caninclude a vacuum connection fitting 232, a shaft rack 234, a vacuum tube236, and a distal vacuum cup 238. Those components of the heartstabilizer assembly 230 are affixed together in the configuration asshown. That is, when the heart stabilizer assembly 230 is moved inrelation to the other parts of the delivery device 200 (while the lockrelease button 214 is depressed), the vacuum connection fitting 232,heart stabilizer shaft rack 234, vacuum tube 236, and vacuum cup 238move as a unit together in the axial direction.

In this embodiment, the vacuum connection fitting 232 is a barbedfitting. Other types of fittings can also be used, such as luerconnections, compressing fittings, threaded fittings, quick-lockfittings, and the like. A source of negative pressure (vacuum) can beconnected via flexible tubing (not shown) to the vacuum connectionfitting 232. The negative pressure will be communicated from the vacuumconnection fitting 232, through the vacuum tube 236, and to the vacuumcup 238.

The shaft rack 234 of the heart stabilizer assembly 230 is configured tobe releasably engageable with the lock release button 214. Engagementbetween the shaft rack 234 and the lock release button 214 effectuatesthe locking of the heart stabilizer assembly 230 in a selected axialposition in relation to the main body 210 and barrel assembly 220.Disengagement of the shaft rack 234 and the lock release button 214(when the lock release button 214 is depressed) unlocks the heartstabilizer assembly 230 such that the heart stabilizer assembly 230 canmove axially in relation to the main body 210 and barrel assembly 220.

In this embodiment, the shaft rack 234 includes a series of holes withwhich one or more protrusions on the shaft lock release button 214engage. When the lock release button 214 is extending outward from themain body 214 (which is the default position of the button 214), the oneor more protrusions on the lock release button 214 extend into one ormore holes on the shaft rack 234 to lock the heart stabilizer assembly230 in place. In contrast, when the lock release button 214 is depressedtowards the main body 214 (e.g., by manually pushing the button 214),the one or more protrusions on the lock release button 214 becomedisengaged from the holes on the shaft rack 234. As a result ofdepressing and maintaining the lock release button 214 in a depressedposition, the heart stabilizer assembly 230 becomes unlocked and free tomove axially in relation to the other parts of the delivery device 200.That is the case because depressing and maintaining the lock releasebutton 214 in a depressed position disengages the protrusions of thelock release button 214 from the holes of the shaft rack 234. When thelock release button 214 is no longer maintained in the depressedposition, the outward bias of the lock release button 214 causes thebutton 214 to translate to an extended position to once again lock theheart stabilizer assembly 230 in relation to the other parts of thedelivery device 200.

In one example, a comparison of FIGS. 6A and 6B illustrates how theheart stabilizer assembly 230 can translate axially when the lockrelease button 214 is pressed. For example, in FIG. 6A the heartstabilizer assembly 230 is in an axially retracted position (a proximalposition). To extend the heart stabilizer assembly 230 distally (e.g.,to the position shown in FIG. 6B), first the lock release button 214 ismanually pressed and maintained in a depressed position, and then theheart stabilizer assembly 230 can be manually slid distally in the axialdirection. In the configuration of FIG. 6B, and as will be describedfurther below, the vacuum cup 238 extends distal-most and is positionedto be the initial member of the delivery device 200 to be inserted intothe chest cavity of a patient during an implant 100 installationprocedure.

Various other design embodiments for locking and unlocking the heartstabilizers are also envisioned. Such embodiments can include the useof, but are not limited to, eccentric collars, cam mechanisms,interlocking tapers, over-center devices, set screws, and the like.

Still referring to FIGS. 6A-6C, the location of the fillable bladder 120on the implant 100, and more specifically, the relative orientation ofthe fillable bladder 120 in relation to the pistol grip handle 212 ofthe delivery device 200 can provide a number of benefits in someembodiments. For example, the implant 100 can be loaded onto thedelivery device 200 in a predetermined orientation such that thelocation of the fillable bladder 120 in relation to the pistol griphandle 212 facilitates alignment of the bladder with a targeted surfaceregion of the heart H during deployed of the implant 100 over the heatH. In such circumstances, a clinician may be able to ascertain theposition of the fillable bladder 120 based on the position of the pistolgrip handle 212. This feature can be advantageous, for example, duringan implantation procedure when the fillable bladder 120 is within thechest cavity of a patient and therefore out of the direct sight of theclinician. For example, during use, the clinician will be estimate thelocation of the fillable bladder 120 relative to the targeted surfaceregion of the heart based on the orientation of the pistol grip handle212 in the clinician's hand.

In this embodiment illustrated in FIG. 6C, when viewing on an axialsight-line in a proximal direction at the distal end of the deliverydevice 200, the fillable bladder 120 is on the left side of the deliverydevice 200 (e.g., at the “9 o'clock” position) when the pistol griphandle 212 is extending vertically downward (e.g., at the “6 o'clock”position). Stated in another way, and as shown in the side views ofFIGS. 6A and 6B, from the perspective of a clinician holding the pistolgrip handle 212 vertically downward and in front of the clinician (e.g.,see FIG. 16A), the fillable bladder 120 is located on the right side ofthe delivery device 200 (e.g., at the “3 o'clock” position relative tothe “6 o'clock” position of the handle 212). Other embodiments may usedifferent variations of orienting a fillable bladder in relation to thedelivery device. For example, in some embodiments the fillable bladdermay be located on the other side of the delivery device, on the upper orlower sides, or at any other position around the periphery of the barrelassembly 220.

Referring now to FIG. 7 (in addition to FIGS. 6A and 6B), someembodiments of the delivery device 200 include multiple epicardialmanagement strips 250 that are positioned between the barrel 222 and theimplant 100 during advancement of the implant 100 toward and over theapex of the heart H. As mentioned previously, epicardial managementstrips 250 can be used to assist with the installation of an implant 100onto the heart H. As the implant 100 is slid over the heart H, theepicardial management strips 250 can be temporarily positioned betweenthe epicardial surface of the heart and the implant 100. The epicardialmanagement strips 250 can be made of a flexible, lubricious material toprovide low-friction surface area that facilitates the slidingadvancement of the implant 100 onto the heart. In this embodiment, theepicardial management strips 250 are components of the delivery device200 and are preloaded on the delivery device 200, as is the implant 100.After the implant 100 is installed and seated in the selected position(e.g., with the hem 113 positioned in the atrial-ventricular groove ofthe heart H), the epicardial management strips 250 are removed from thechest cavity.

The epicardial management strips 250 can be made from a variety ofdifferent materials, including but not limited to,polytetrafluoroethylene (PTFE), expanded-PTFE (ePTFE),ultra-high-molecular-weight polyethylene (UHMWPE), fluorinated ethylenepropylene (FEP), perfluoroalkoxy (PFA), and the like. In someembodiments, a lubricious coating or surface treatment can be applied tothe material used to make the epicardial management strips 250. Thematerials selected to construct the epicardial management strips 250have properties such as a low coefficient of friction, biocompatibility,and resistance to absorption of liquids. The thickness of the epicardialmanagement strips 250 can be selected to provide the desired levels oflateral flexibility, column strength, and other mechanical properties.For example, in some embodiments the thickness of the epicardialmanagement strips 250 are in the range of about 0.010 inches to about0.100 inches (about 0.25 mm to about 2.54 mm).

In this embodiment, there are a total of six epicardial managementstrips 250. The epicardial management strips 250 extend from theactuators 224, over the external surface of the barrel 222, under theimplant 100, and terminate where the implant 100 is coupled to thedelivery device 200. In this embodiment, the epicardial managementstrips 250 include a proximal portion 252, a distal portion 254, and anintermediate portion 256 therebetween. The proximal portion 252 includesa first clearance hole 253 that is configured to engage with a barbedprotrusion located on the actuators 224. The distal portion 254 is awidened area that slides on the heart's surface as an implant 100 isbeing installed. A second clearance hole 255 is located at the distalportion 254. The second clearance hole 255 is configured to allow aportion of the mesh material of the implant 100 to pass therethrough,whereafter the portion of mesh material is releasably coupled with thedelivery device 200.

Referring now to FIGS. 8A-8E, the delivery device 200 is illustratedfrom multiple perspectives. In these views, the implant 100 andepicardial management strips 250 are not shown for purposes ofillustrating the barrel assembly 220 and other components distalthereto. As described previously, the delivery device 200 includes themain body 210, barrel assembly 220, and heart stabilizer assembly 230.In addition, the delivery device 200 includes multiple elongate armassemblies 240. As described further herein, the arm assemblies 240 canbe individually and selectively extended from the barrel assembly 220 toconvey the implant 100 onto a heart. Thereafter, the arm assemblies 240can be decoupled from the implant 100 and retracted from the patient'schest space (along with the epicardial management strips 250 not shownin FIGS. 8A-8E), while the implant 100 remains in a selected position onthe patient's heart H (e.g., with the hem 113 positioned in theatrial-ventricular groove of the heart H).

The arm assemblies 240 extend from the distal end of the barrel assembly220 and terminate at free ends 244. A proximal end of each arm assembly240 is coupled to an actuator 224. In this embodiment, the deliverydevice 200 includes six actuators 224 and six corresponding armassemblies 240. Other embodiments may include more than six or fewerthan six actuators and arm assemblies. In this embodiment, each actuator224 is coupled to one and only one arm assembly 240, and each armassembly 240 is coupled to one and only one actuator 224. However, insome embodiments, more than one arm assembly may be coupled to oneactuator. As described further herein, the distal free ends 244 of thearm assemblies 240 are configured to releasably couple with the meshmaterial of an implant (refer, for example, to FIG. 6C).

Referring to FIGS. 8F and 8G, the elongate arm assemblies 240 arelaterally flexible and axially extendable members. That is, each of thearm assemblies 240 can elastically bend laterally and translate axiallyin the depicted embodiment. Such properties can be useful for conveyingan implant through a relatively small chest opening, into thepericardial cavity of a patient, and then onto the ventricles of thepatient's heart H in an atraumatic manner.

In this embodiment of the delivery device 200, the elongate armassemblies 240 can be manually adjusted between a retracted position(depicted in FIG. 8F) and an extended position (depicted in FIG. 8G). Inthe extended position, the elongate arm assemblies 240 project distallyfrom the distal end 221 of the barrel assembly 220 to a greater extentthan when the arm assemblies 240 are in the retracted position. Thisability of the arm assemblies 240 to extend distally is useful for thepurpose of conveying an implant onto the heart of a patient. That is,while the distal end 221 of the barrel assembly 220 remains outside ofthe chest cavity, the arm assemblies 240 can be extended through a chestincision, and then extended into the chest cavity of the patient. Thearm assemblies 240 can be extended further to project around theventricles of the patient's heart to place the implant 100 onto theheart H (e.g., refer to FIGS. 1B, 4A, and 4B). The flexibility of thearm assemblies 240 can be useful because the arm assemblies sustainflexure during the minimally invasive implantation procedure. Forexample, after passing through the chest incision, at least some of thearm assemblies 240 thereafter bend to follow the contours of the heartH. Because the arm assemblies 240 are laterally compliant, the armassemblies 240 can enter the chest through a small incision (e.g., amini-thoracotomy) and elastically flex within the chest cavity to conveyan implant 100 onto the patient's heart H.

In the depicted embodiment, the arm assemblies 240 can be extended andretracted by moving the arm actuators 224. That is the case, because theproximal ends of the arm assemblies 240 are coupled to the actuators224. In order to axially move an arm assembly 240, the correspondingactuator 224 can be slid along the splined elongate barrel 222. Forexample, because the actuators 224 are located near the proximal end ofthe splined elongate barrel 222 in FIG. 8F, the arm assemblies 240 arein retracted positions. In contrast, because the actuators 224 arelocated near the distal end of the splined elongate barrel 222 in FIG.8G, the arm assemblies 240 are in extended positions.

Referring to FIGS. 9A-9C, the arm actuators 224, and the correspondingarm assemblies 240 coupled thereto, can be individually axiallytranslated along the axis of the splined elongate barrel 222. Forexample, arm actuator 214 a has been slid to a location that is distalof the other arm actuators 224. The corresponding arm assembly 240 a istherefore extended further distally from the distal end 221 of thebarrel 222 than the other arm assemblies 240. In some embodiments,multiple arm actuators 224 and arm assemblies 240 can be movedconcurrently using a mechanical member that simultaneously translatesthe multiple arm actuators 224.

In this embodiment of the delivery device 200, the actuators 224 and thearm assemblies 240 are each individually slidably coupled with a spline223 of the barrel 222. Each arm assembly 240 can be at least partiallydisposed in a corresponding spline 223 of the splined elongate barrel222. For example, arm assembly 240 a is partially disposed in spline 223a. The open space defined by the splines 223 is larger than the outerprofile of the portion of the arm assemblies 240 disposed therein. Assuch, the arm assemblies 240 are free to slide axially within thesplines 223. The arm actuators 224 are also partially disposed in orengaged with a particular spline 223. For example, arm actuator 224 a isengaged with spline 223 a. The arm actuators 224 include shuttleportions that have shapes that are complementary to the shape of thesplines 223. As a result, the arm actuators 224 are coupled to, and areslidable in relation to, the splines 223.

Referring to FIGS. 9A-9C and FIG. 10, the main body 210 can include anactuator lock ring 216. The actuator lock ring 216 can be operated toretain the arm actuators 224 at the arm actuator's 224 proximal-mostposition on the barrel 222. This feature can be useful for purposes ofrestraining the arm assemblies 240 from inadvertently extending.

The actuator lock ring 216 can be rotatably coupled to the main body210. That is, in this embodiment the actuator lock ring 216 is coupledto, and is free to be manually rotated in relation to the main body 210.In addition, the actuator lock ring 216 can be manually rotated inrelation to the barrel 222 and the arm actuators 224 slidably coupledthereto.

The actuator lock ring 216 includes a rotatable lock knob 218 that canbe manually rotated to lock or unlock the actuators 224 to the main body210. The actuator lock ring 216 also includes six slots 217 (shown inFIG. 10) that are disposed about the inner diameter of the ring 216. Theslots 217 are configured to be selectively alignable with the splines223 of the barrel 222. The slots 217 are also configured to receiveactuator tabs 225 (refer to FIG. 9C) that are located on the proximalends of the arm actuators 224. When the slots 217 of the actuator lockring 216 are in alignment with the splines 223, and the arm actuators224 are slid to the distal-most end of travel on the barrel 222, thenthe tabs 225 pass through the slots 217 and reside proximally to theslots 217. Thereafter, the actuator lock ring 216 can be rotated via thelock knob 218 such that the slots 217 are no longer aligned with thesplines 223, thereby locking the arm actuators 224 to the main body 210.For example, in FIG. 9A the actuator lock ring 216 is in a rotaryposition where the slots 217 are not aligned with the splines 223.Therefore, the arm actuators 224, other than actuator 224 a, are lockedto the main body 210. In contrast, in FIG. 9B the actuator lock ring 216is in a rotary position where the slots 217 are aligned with the splines223. For instance, slot 217 a is visibly aligned with slot 223 a.Therefore, all of the arm actuators 224 are not locked to the main body210. In result, the arm actuators 224 can be slid in relation to themain body 210 and splined barrel 222.

In the cross-sectional view of FIG. 9B, it can be seen that each of thearm assemblies 240 include an elongate hollow outer jacket 241. Thehollow outer jacket 241 defines an open interior space, or lumen, thatcan contain another member, such as a core member 242 described inconnection with FIGS. 11A-11B.

Referring now to FIGS. 11A and 11B, in this embodiment each of the armassemblies 240 include the hollow outer jacket 241, the core member 242,and an arm cap 243. The core member 242 is slidably disposed within thelumen of the hollow outer jacket 241. The arm cap 243 is affixed to thedistal end of the hollow outer jacket 241. Therefore, the core member242 can also be slid in relation to the arm cap 243. In otherembodiments, other configurations of the arm assemblies 240 can be usedwhile providing similar functionality.

As described previously, arm actuators 224 are coupled to correspondingarm assemblies 240. For example, when an arm actuator 224 is axiallytranslated in relation to the splined barrel 222, a corresponding armassembly 240 is extended or retracted from the distal end 221 of thebarrel 222. As each arm assembly 240 is extended or retracted, thehollow outer jacket 241, core member 242, and arm cap 243 of the armassembly 240 can be extended or retracted in equal distances, and inunison.

The arm actuators 224 are coupled to arm assemblies 240 in a secondmanner that allows each actuator 224 to move the core members 242 of thecorresponding arm assembly 240 relative to the hollow outer jacket 241and arm cap 243. In particular, the arm actuators 224 are coupled to thecore members 242 such that pivoting an actuator lever 226 of an armactuator 224 can advance or retract a core member 242 of an arm assembly240 in relation to the outer jacket 241 and arm end 243 of the armassembly 240. The pivotable actuator lever 226 of an actuator 224controls the core member 242 of the arm assembly 240 to which theactuator 224 is coupled.

The pivotable actuator lever 226 is shown pivoted away from the barrel222 in FIG. 11A, such that the longitudinal axis of the pivotableactuator lever 226 is roughly perpendicular to the axis of the barrel222. In contrast, the pivotable actuator lever 226 is shown pivotedtoward the barrel 222 in FIG. 11B, such that the longitudinal axis ofthe pivotable actuator lever 226 is roughly parallel with the axis ofthe barrel 222. Such pivoting of the actuator lever 226 controls theaxial position of the core member 242 in relation to the hollow outerjacket 241 and the arm cap 243. For example, in FIG. 11A no core memberis visible within the window of the arm cap 243. In contrast, in FIG.11B, the core member 242 is visible within the window of the arm cap243. This comparison illustrates that, in this embodiment, when anactuator lever 226 is pivoted away from the barrel 222, a core member242 is retracted in the axial direction. Conversely, when an actuatorlever 226 is pivoted toward the barrel 222, a core member 242 isadvanced distally in the axial direction.

This second manner by which arm actuators 224 are coupled to armassemblies 240 can be operated independently of axially translating anarm actuator 224 in relation to the splined barrel 222 to extend orretract a corresponding arm assembly 240. So, for example, at any axialposition of an arm actuator 224, the actuator lever 226 can be pivotedto advance or retract the core member 242. Further, the two movements(axial translation of an arm actuator 224 and pivoting of the actuatorlever 226) can be performed contemporaneously.

The advancing and retracting of the core members 242 within the windowsof the arm ends 243 can be advantageously used for releasably couplingan implant to the delivery device 200. In some embodiments, a portion ofthe mesh body 110 of the implant 100 can be crimped and contained withina window of an arm end 243 (refer, for example, to FIG. 6C) when thecore member 242 is in the advanced position. When it is desired torelease the implant 100 from the delivery device 200, the actuatorlevers 226 can be pivoted to retract the core members 242, and the meshmaterial will then no longer be crimped within the windows of the armends 243, and the implant 100 can then be separated from the deliverydevice 200. Thereafter, the arm assemblies 240 can be retracted from thepatient's chest space (along with the epicardial management strips 250not shown in FIGS. 8A-11B), while the implant 100 remains in a selectedposition on the patient's heart H (e.g., with the hem 113 positioned inthe atrial-ventricular groove of the heart H).

Referring now to FIGS. 12A-12C, some embodiments described hereininclude a method 300 for installing an implant in a patient to treat aheart condition. In some implementations, such heart conditions caninclude, but are not limited to, functional mitral regurgitation,tricuspid valve regurgitation, and congestive heart failure. In someembodiments of the method 300, a cardiac implant (including but notlimited to the implant 100 described above) is implanted to surround anexterior portion of the patient's heart. The implant employed in themethod 300 may include one or more fillable bladders. The fillablebladders can be configured for installation at a selected position onthe targeted epicardial region of the heart (for example, on a posteriorwall of the heart adjacent the mitral valve) so that the fillablebladder will exert a localized pressure to induce the remodeling of aportion of the heart when the fillable bladder is inflated. In theexample of positioning a fillable bladder on a posterior wall of theheart adjacent the mitral valve, the fillable bladder provides localizedpressure that in turn is applied to a posterior portion of the mitralvalve annulus (refer to FIG. 1), thus bringing the leaflets of the valveinto closer proximity with one another and treating a mitral valveregurgitation problem.

Referring to FIG. 12A, in some implementations of the method 300, step302 includes identifying the apex of a patient's heart. This step mayinvolve the use of one or more imagining modalities. For example, insome embodiments, radiographic and/or transthoracic echocardiographicinformation is attained to assist in the identification of the apex ofthe heart.

At step 304 in some implementations of the method 300, a location for anincision to access the patient's heart is selected, and then an incisionthrough the patient's skin is made. In some embodiments, the selectedlocation of the incision will allow access to the apex of the heart inalignment with the long axis of the heart. Such an incision can allow animplant delivery device to be inserted into the patient's chest cavitysubstantially coaxially with the heart (e.g., as in step 326).Therefore, the location for the incision can be made at least partlybased on the location of the apex of the patient's heart as ascertainedin step 302. In some implementations, an intercostal incision locationis selected. For example, in particular implementations the fifthintercostal space may be selected. However, the selected incisionlocation can be patient-specific. In some implementations, the incisioncomprises a mini-thoracotomy heart access procedure. In some embodimentsof method 300, a minimum size of incision is recommended. For example,for the delivery device 200 described above, a minimum incision of 7 cmis recommended, although that is optional in some implementations.

At step 306 in some implementations of the method 300, surgicalretraction is performed to create and maintain a surgical passagewaythrough the patient's incised skin. In some implementations, alow-profile retractor is used. In some embodiments of method 300, aseparation distance of the retractor blades is recommended. For example,when the delivery device 200 described above will be used, the retractorblades should be separated by at least about 4 cm.

At step 308 in some implementations of the method 300, the pericardiumis incised and retracted to provide access to the heart's apex. In someembodiments, the selected location of the incision will allow access tothe apex of the heart in alignment with the long axis of the heart. Insome embodiments of method 300, a minimum size of incision isrecommended. For example, for the delivery device 200 described above, aminimum incision of 7 cm is recommended, although that is optional. Theedges of the pericardium can be retracted by suturing the edges to thesurrounding tissues.

At step 310 in some implementations of the method 300, an inspection ismade for pericardial adhesions. Pericardial adhesions are an attachmentof the pericardium to the heart muscle. In some implementations,contrast agent solution may be injected into the pericardium to enhancevisualization of pericardial adhesions. If pericardial adhesions thatmay impede complete circumferential access to the heart are identified,the clinician may abandon the method 300 at this point.

At step 312 in some implementations of the method 300, multiplepericardial edge management strips (PEMS) are installed. The PEMS can beused to cover exposed edges of the pericardium, and to create a cleartunnel for access (e.g., by delivery tool 200) to the apex of the heart.In some implementations, four to six PEMS are installed. In otherimplementations, fewer than four or more than six PEMS may be installed.The PEMS are sterile devices.

One example embodiment of PEMS is illustrated in FIGS. 13A and 13 B. Asshown, in some embodiments the PEMS 400 includes a masking member 410, amalleable member 420, and an adhesive member 430. The malleable member420 and the adhesive member 430 can be attached to the masking member410. In some embodiments, the malleable member 420 is disposed betweenmultiple layers of masking member 410 material. The masking member 410can be a flexible biocompatible film such as Teflon, polyester,polyurethane, and the like. The malleable member 420 can be a thin gaugemetallic material, such as a stainless steel, titanium, and the like, oralloys thereof. The adhesive member 430 can be a pressure-sensitivebiocompatible material such as a medical-grade acrylic adhesive, orother medical-grade adhesives. The adhesive member 430 can comprise anadhesive pad or be coated onto the masking member 410. The adhesivemember 430 is covered by a liner 432 that is removed when the PEMS 400are put into use.

One non-limiting example of step 312 (using the PEMS 400) is illustratedin FIG. 13C. A retractor device 440 for spreading open an incision inthe chest 460 of a patient depicted. Four PEMS 400 are partiallyinserted in the chest cavity of a patient to create an access tunnel450. The end opposite the adhesive member 430 is inserted through theincision and into the pericardial space. Care is used to ensure that theinserted end of the PEMS 400 is within the pericardial space and is notinserted too deep into the incision such that the PEMS 400 willinterfere or damage other cardiac structures. The exposed portion of thePEMS 400 is bent back (thereby deforming the malleable member 420) sothat the PEMS 400 is in contact with the sterile surgical drape aroundthe incision site. The adhesive liner 432 is removed. The adhesivemember 430 of the PEMS 400 is adhered to the sterile surgical draping onthe chest 460 of the patient. This process is repeated with additionalPEMS 400 until the all edges of the pericardium are covered by PEMS 400.

Referring again to FIG. 12A, in some implementations of the method 300,step 314 includes identifying the atrial-ventricular groove. In someimplementations, the atrial-ventricular groove is identified usingfluoroscopy. Multiple fluoroscopic images from various angles may needto be used to ascertain the location of the atrial-ventricular groove.In some implementations, the injection of a contrast solution into thepericardial space (e.g., between the pericardium and the epicardium) mayenhance the visibility of the atrial-ventricular groove. The boundariesof other cardiac structures may also be determined in this step.

In some implementations of the method 300, the optional step 316includes intra-operatively measuring the ventricular perimeter of thepatient's heart. In some instances, the measurement may have alreadybeen performed pre-operatively using imaging modalities such as a CATscan, MRI, ultrasound, and the like. In such instances, step 316 may beoptional to perform.

An example intra-operative sizing device 500 for performing step 316 isdepicted in FIGS. 14A-14C. In some embodiments, the sizing device 500includes a main body 510, a vacuum assembly 520, sizing arms 530, andsizing cords 540. The vacuum assembly 520 is slidable in relation to themain body 510. The arms 530 are fixed to the main body 510. The cords540 (in the embodiment depicted there are three cords) are attached atone end to the end cap 532 of one of the arms 530, and at another end toa sizing positioner 512 in the main body 510.

In some embodiments, the main body 510 includes a casing 511, sizingpositioners 512, a sizing indicator 513, and a sizing scale 514. Thesizing positioners 512, which are linked to the sizing indicator 513,are slidable in relation to the casing 511. The sizing scale 514 isaffixed to the casing. As the sizing positioners 512 are axiallytranslated, the sizing indicator 513 moves in unison. The clinician canascertain the measurement by viewing the sizing indicator 513 inrelation to the sizing scale 514.

The sizing device 500 also includes a vacuum assembly 520. In someembodiments, the vacuum assembly 520 can include a vacuum fitting 521, aknob 522, a vacuum shaft 523, and a vacuum stabilizer cup 524. Theaforementioned components of the vacuum assembly 520 are affixed to eachother and axially translate in relation to the main body 510 as a unit.The vacuum fitting 52 is in fluid communication with the vacuum shaft523, which is in fluid communication with the vacuum stabilizer cup 524.Hence, when a source of negative pressure is attached to the vacuumfitting, negative pressure is communicated to the vacuum shaft 523 andvacuum stabilizer cup 524.

In some embodiments, the sizing device 500 also includes multiple sizingarms 530. In the depicted embodiment, three arms 530 are included thatare disposed at about 120 degrees apart from each other. In otherembodiments, fewer or more arms are included. One end of the arms areaffixed to the main body 510, while the other ends of the arms 530 arefree ends having end caps 532. The arms 530 are laterally elasticallyflexible. That is, the arms 530 can radially deflect away from thevacuum shaft 523 while having one end affixed to the main body 510. Assuch, in some embodiments the arms 530 are made from a polymericmaterial such as Acrylonitrile Butadiene Styrene (ABS), PolyvinylChloride (PVC), Cellulose Acetate Butyrate (CAB), Polyethylene (PE),High Density Polyethylene (HDPE), Low Density Polyethylene (LDPE orLLDPE), Polypropylene (PP), Polymethylpentene (PMP), Polycarbonate (PC),Polypheneylene Ether (PPE), Polyamide (PA or Nylon), and the like. Theend caps 532 include clearance holes through which a sizing cord 540freely passes.

The sizing device 500 also includes sizing cords 540. In the embodimentdepicted, three sizing cords 540 are included. In other embodiments,fewer or more cords are included. The cords can be comprised of abiocompatible material such as, but not limited to, PTFE, ePTFE,polypropylene, polyglycolide, nylon, and other like materials. Each cord540 have two ends. A first end of the cords 540 is attached to thesizing positioners 512, and a second end of the cords are individuallyattached to an end cap 532. Therebetween, the cords 540 individuallypass through a clearance hole in an end cap 532.

In one embodiment, the process for using the sizing device 500 is asfollows. A source of negative pressure is connected to the vacuumfitting 521. The vacuum assembly 520 is fully extended in relation tothe main body 510. The vacuum stabilizer cup 524 is inserted through thechest incision and placed in contact with the apex of the heart. Themain body 510, and sizing arms 530 affixed thereto, are carefullyadvanced into the pericardial cavity so that the arms 530 and the cords540 surround the heart. An imaging system, such as a fluoroscope, can beused to provide visualization of the advancement. As the arms and cords540 are advanced, the sizing positioners 512 may move distally inrelation to the main body 510 as the cords 540 require additional lengthto surround the heart. The advancement is stopped when the sizer cords540 are around the largest perimeter of the heart. The sizer positioners512 are then carefully pulled back (manually) to remove any slack in thecords 540. Using fluoroscopy, the clinician confirms that the cords 540are not over-tightened (e.g., that the heart is not indented by thecords 540). The clinician then observes the relative position of thesizing indicator 513 to the sizing scale 514. The clinician can therebyascertain the size of the largest perimeter of the heart, and thereafterremove the sizing device 500.

Referring again to FIG. 12A, in some implementations of the method 300,step 318 can include selecting an implant, which may be includeselecting the implant based at least in part on the size of thepatient's heart as determined previously. In some embodiments, theimplant will be pre-loaded on a delivery device in sterile packaging, aspreviously described herein. The epicardial management strips may alsobe pre-loaded on the delivery device.

At step 320 in some implementations of the method 300, a source ofnegative pressure is connected to the delivery device. In the context ofthe example delivery device 200, the negative pressure is attached tovacuum connection fitting 232. The negative pressure will becommunicated to the vacuum cup 238 of the heart stabilizer 230.

At step 322 in some implementations of the method 300, the vacuumstabilizer is fully extended. In the context of the example deliverydevice 200, the heart stabilizer 230 is fully extended in relation tothe main body 210.

At step 324 in some implementations of the method 300, the vacuumstabilizer is inserted through the incision and into pericardial tunnel.An example of this step is illustrated in FIG. 15. There the vacuum cup238 of example delivery device 200 is being inserted into thepericardial tunnel 450. The implant 100 is coupled to the deliverydevice 200.

Referring now to FIG. 12B, at step 326 the fillable bladder isrotationally aligned to a target location on the heart, in accordancewith some implementations of the method 300. For example, in someinstances the target location may be on the posterior lateral surface ofthe heart where the fillable bladder will be able to deflect the “P2”portion of the posterior leaflet of the mitral valve to treat FMR. Othertarget locations may be selected in other instances depending on thecondition to be treated using method 300. In this step, the relativepositioning between features of the delivery device and the fillablebladder can be used advantageously. In the context of the exampledelivery device 200, as explained above, the relative orientation of thefillable bladder 120 in relation to the pistol grip handle 212 of thedelivery device 200 can have a predetermined orientation such that aclinician may be able to ascertain the position of the fillable bladder120 based on the conveniently held position of the pistol grip handle212 over the patient's body. Based on the known orientation, theclinician will be estimate the location of the fillable bladder 120relative to the targeted surface region of the heart based on theorientation of the pistol grip handle 212 in the clinician's hand.

At step 328 in some implementations of the method 300, the vacuumstabilizer is applied to the apex of the patient's heart. The negativepressure at the delivery device is active at this step. Therefore, thevacuum stabilizer becomes attached to the apex using vacuum. The apex ofthe heart is thereby stabilized in relation to the delivery device.

At step 330, the arm actuators can be unlocked. In the context of theexample delivery device 200, the clinician rotates the actuator lockring 216, as previously described. Thereafter, all of the arm actuators224 are not locked to the main body 210, and the arm actuators 224 canbe slid in relation to the main body 210 and splined barrel 222 of thedelivery device 200.

At optional step 332 in some implementations of the method 300, theheart can be temporarily elongated. The clinician can perform this stepby exerting a slight directed pull on the delivery device in a proximaldirection. Doing so may elongate the shape of the heart at the heart'sapex and ease the initial deployment of the delivery tool's arms overthe heart.

At step 334, the arms of the delivery device are incrementally extendedwhile using imaging to view the position of the arms relative to theheart. FIGS. 16A-16C illustrate one non-limiting example of the step334, in accordance with some implementations of the method 300. In FIG.16A a clinician is shown operating a delivery device 200. The clinicianis extending the arms 240 of the delivery device, incrementally andindividually, by sliding the actuators 224 distally. Contemporaneously,the clinician is observing the video screen of an imaging system 600(refer to FIG. 16B) whereby the clinician can view the positions of thearms 240 in relation to the heart H. In some implementations, theradiopaque markers of the implant 100 (described above) may also aid inthe contemporaneous visualization process and to verify the positioningof the hem 113 and the bladder 120 relative to particular landmarks ofthe heart H. FIG. 16C illustrates an implant 100 that is coupled to arms240 as the arms are being extended so as to position the implant 100around the ventricles of the heart H. The arms 240 are advancedcarefully, and in many circumstances, no single arm 240 is greatlyadvanced further than the others. For example, in some implementationsit is recommended that no single arm 240 be positioned more than about 2cm beyond any other arm 240. In some implementations, it may beadvantageous to modulate the extension distance of the vacuum stabilizerin relation to the rest of the delivery device so as to achieve adesirable balance between flexibility and column strength of the armsduring this step.

At step 336, the arms are further advanced to position the leading hemof the implant in the atrial-ventricular groove of the heart. Thispositioning of the implant in the atrial-ventricular groove is depictedin FIG. 1B, for example. As previously described herein, radiopaquemarkers may be mounted on the implant to assist with the contemporaneousvisualization process and to verify the positioning of the hem 113 andthe bladder 120 relative to particular landmarks of the heart H. In thecontext of the example delivery device 200, one or more radiopaquemarkers 115 located on the hem 113 and one or more radiopaque markers125 of the bladder 120 can be used as reference points in conjunctionwith an imaging system.

At step 338, the delivery device is decoupled from the implant. In thecontext of the example delivery device 200, pivoting an actuator lever226 of an arm actuator 224 can retract a core member 242 of an armassembly 240 in relation to the outer jacket 241 and arm end 243 of thearm assembly 240 to decouple the arm assembly 240 from the implant 100.This process can be repeated for every arm assembly 240 to fullydecouple the implant 100 from the delivery device 200.

At step 340 the arms of the delivery device can be retracted. Forinstance, using the delivery device 200 as an example, the arm actuators224 can be slid proximally to withdraw each arm assembly while leavingthe implant 100 on the heart H. The epicardial management strips 250 arealso retracted along with the arms 240.

At step 342, the delivery device is withdrawn from the patient. Thenegative pressure source is discontinued, and then the entire deliverydevice is withdrawn. One non-limiting example of this step isillustrated in FIG. 17.

Referring again to FIG. 12B, at step 344 the fillable bladder(s) areinflated while patient parameters are monitored. Sterile saline solutionor other types of inflation fluids may be used to inflate fillablebladders. For example, the inflation fluid can be dispensed from asyringe device or other inflation delivery device that is temporarilycoupled to the proximal end opening of the tube. When the conditionbeing treated is valvular regurgitation, the valve may be monitoredusing, for example, transesophageal echocardiography or other liketechniques, while the inflation is taking place. Such contemporaneousmonitoring may assist the clinician to determine the volume of inflationfluid to administer into the fillable bladder(s). This step is alsoillustrated in FIG. 17.

Referring again to FIG. 12B, at step 346, the inflation tube of thefillable bladder is sealed. For example, one or more ligation clips maybe applied to the inflation tube to seal the tube (refer, for example,to FIGS. 1A and 1).

Referring now to FIG. 12C, in some implementations of the method 300,step 348 may include flushing the pericardial cavity. For example,sterile saline solution can be injected and subsequently aspirated. Thisstep can be performed to remove contrast agent substances that may havebeen injected earlier in the procedure. The injection and aspiration ofthe solution can be repeated multiple times, as desired, to flush thepericardial cavity.

At step 350, the pericardial edge management strips are removed. Theremoval can be performed by reversing the steps of the implementationprocedure.

At step 352, excess mesh material of the implant is trimmed. This step352, like all other steps in some implementations of the method 300, maybe performed while the heart is beating. In such circumstances, theclinician can carefully gather the trailing end material of the implantin the area of the chest opening. Using a scissors or other cuttingdevice, the clinician can trim the excess material. Care is taken toensure a sufficient amount remains with the implant to close the implantaround the apex of the heart. One non-limiting example of this step isillustrated in FIG. 18.

Referring again to FIG. 12C, at step 354 the trailing end of the implantis closed around the apex of the heart. This can be performed bysuturing the trailing end portion and cinching the material togetherlike a purse string. The inflation tube remains extending through thecinched trailing end portion. One non-limiting example of thisconfiguration is illustrated in FIG. 1B.

Referring again to FIG. 12C, at step 356 the pericardium is looselyclosed. This step can be performed by installing a few sutures (e.g.,two or three) to close the pericardium. Having a loose closure willfacilitate drainage of fluids form the pericardium, as is common after aprocedure such as this. The inflation tube remains extending through theloosely closed pericardium.

At step 358, the end of the inflation tube is aligned in an intercostalspace and the chest incision is closed. Aligning the end of theinflation tube in the intercostal space may allow future access to theinflation tube via a simple cut-down procedure through the skin adjacentto the intercostal space between the ribs (e.g., the fifth intercostalspace in some implementations). Future inflation or deflation of thefillable bladder may thereby be performed with a minimally invasiveaccess to an intercostal space under the side without extensive surgeryto access the pericardium or epicardium.

Referring to FIG. 19, the heart H can be treated (e.g., to reduce FMR)using an implant 1 that includes a jacket 10 and multiple inflatablebladders that facilitate exertion of localized pressure on theepicardium at two or more particular strategic locations. In thedepicted example, a first inflatable bladder 20A is positioned on thewall of the heart H near the mitral valve, e.g., at the P2 area of themitral valve (in the center of the posterior leaflet) to reduce thedistance across the valve, thereby potentially reducing the gap betweenthe leaflets responsible for the regurgitation. Additionally, it may beadvantageous to also exert localized pressure on the epicardium nearpapillary muscles from which chordae extend to the valve leaflets. Forexample, a second inflatable bladder 20B can be positioned to exertlocalized pressure to the wall of heart H resulting in an advantageousdisplacement of anterior papillary muscles. Further, in some cases athird inflatable bladder 20C can be positioned to exert additionallocalized pressure to the wall of heart H resulting in an advantageousdisplacement of posterior papillary muscles. In some cases, two and onlytwo bladders 20A and 20B, or 20A and 20C are included as part of theimplant 1. In some cases, all three bladders 20A, 20B, and 20A areincluded as part of the implant 1.

The inflatable bladders 20A, 20B, and/or 20C may be disposed on aninterior surface of jacket 10. Bladders 20A, 20B, and/or 20C may or maynot be attached to jacket 10. In embodiments wherein the bladders 20A,20B, and/or 20C are attached to the jacket 10 prior to implantation ofthe implant 1, the implant may include one, two or all of the threebladders 20A-C. When bladders 20B and/or 20C are positioned adjacent tothe papillary muscles, the bladders can be inflated to gently correctpapillary muscle position and relieve tension on the chordae (whichotherwise prohibits normal valve functioning).

Referring to FIG. 20, an enlarged heart H is shown in longitudinalcross-section. The enlarged left ventricle LV of the heart H is causingFMR in this example. Such FMR is occurring because the left ventricle LVis distorted or dilated (enlarged), displacing the papillary muscles andchordae that support the two mitral valve leaflets, thereby stretchingthe mitral valve opening (annulus) as depicted in FIG. 20.

Referring also to FIG. 21, a first fillable bladder 21A (e.g., coupledto the mesh body of a jacket at a specific location) can be used toexert a localized pressure on the posterior lateral surface of the heartH to thereby deflect the “P2” portion of the posterior leaflet of themitral valve in an attempt to treat the FMR. While such a treatment mayserve reduce or eliminate FMR in some cases, in other cases (such as thedepicted example) the effects of the distended left ventricle LV on thepapillary muscles and chordae are not fully overcome by use of thesingle bladder 21A.

Referring also to FIG. 22, in some cases the effects of displacedpapillary muscles and chordae that result from the distorted or dilatedleft ventricle LV can be counteracted by the use of a second fillablebladder 21B (e.g., coupled to the mesh body of a jacket at a specificlocation). The second fillable bladder 21B can exert localized pressureon the wall of the heart H adjacent to the effected papillary muscles.Accordingly, the second fillable bladder 21B can be inflated to gentlycorrect papillary muscle position and relieve tension on the chordae(which otherwise prohibits normal mitral valve functioning). Such aconcerted local pressurization on the heart H at: (i) the mitral valveannulus and (ii) the left ventricular wall at the location of effectedpapillary muscles, can be used to effectively reduce or eliminate FMR ofan enlarged heart H in many cases.

Referring to FIG. 23, an example inflatable bladder 800 can be used withthe cardiac implant devices (jackets) described herein. Inflatablebladder 800 is designed to have an extra-low profile when uninflated,and to be highly expandable in response to inflation. To achieve thehighly expandable design, the inflatable bladder 800 has special sidewalls that are formed with undulations like a bellows. Such side wallsmake inflatable bladder 800 highly expandable.

The inflatable bladder 800 can be made of any of the materials, shapes,and can be made using any of the construction techniques that aredescribed above in reference to fillable bladders, such as the fillablebladders 20 and 120. In some cases, the inner layer of the inflatablebladder 800 is more compliant than the outer layer of the inflatablebladder 800. Alternatively, in some cases the inner and outer layers ofthe inflatable bladder 800 are made of materials having the samecompliance. In some such cases, the inflatable bladder 800 is expandablewithout stretching the materials of the layers. Such a design canprovide enhanced fatigue resistance of the inflatable bladder 800 insome cases.

Referring also to FIG. 24, the inflatable bladder 800 (shown here in atransverse cross-section view) includes a base layer 810 and anexpanding layer 820. The base layer 810 and the expanding layer 820 arebonded together (in a sealed manner) around the periphery of theinflatable bladder 800. In some embodiments, an intermediate layer isinterposed between the base layer 810 and the expanding layer 820 aroundthe periphery of the inflatable bladder 800. An inflation tube 830,which is in fluid communication with the interior space of the bladderthat is defined between the base layer 810 and the expanding layer 820,extends therefrom. The inflation tube 830 is used to convey an inflationfluid into and/or out of the inflatable bladder 800.

The expanding layer 820 includes a peripheral side wall 822 and apressure-exerting surface 824 positioned within the periphery of theperipheral side wall 822. The pressure-exerting surface 824 is generallyplanar in some embodiments. The peripheral side wall 822 includes one ormore undulations (e.g., one, two as shown, three, four, five, six, ormore than six undulations). The undulations act like the folds of abellows (or an accordion) to allow the inflatable bladder 800 totransition between a low profile (as shown) to a substantially expandedprofile. Moreover, the transition between a low profile to asubstantially expanded profile can be accomplished without materialstretching, if so desired.

Referring to FIG. 25, the inflatable bladder 800 is again shown in atransverse cross-section view. Here, however, the inflatable bladder 800has been inflated so that it is enlarged to a first expanded size. Inthis first expanded size, one of the undulations (folds) of theperipheral side wall 822 has unfolded in response to a pressure increasein the interior space of the inflatable bladder 800 from an infilling ofan inflation fluid. As a result, the pressure-exerting surface 824 hasmoved away from the base layer 810. In this manner, pressure can beexerted by inflatable bladder 800 to a heart wall to treat conditionssuch as FMR.

Referring also to FIG. 26, if additional inflation fluid is added to theinterior space of the inflatable bladder 800, the pressure-exertingsurface 824 will move still farther away from the base layer 810. In thedepicted arrangement, for example, the second undulation (fold) of theperipheral side wall 822 has unfolded in response to a pressure increasein the interior space of the inflatable bladder 800 from an additionalinfilling of an inflation fluid (in comparison to the arrangement ofFIG. 25). It should be understood that, in some embodiments, theexpansion of the inflatable bladder 800 as shown can occur withoutextension (stretching or elongation) of the materials of thepressure-exerting surface 824 and the base layer 810.

In one example embodiment of the inflatable bladder 800, therelationship between the volume of the interior space of the inflatablebladder 800 and the height H of the inflatable bladder 800 is asfollows: when the volume is 20 ml the height H is 10.7 mm, when thevolume is 40 ml the height H is 18.3 mm, when the volume is 60 ml theheight H is 27.4 mm, when the volume is 80 ml the height H is 36.8 mm,when the volume is 90 ml the height H is 41.9 mm, and when the volume is100 ml the height H is 44.2 mm (a more than four-fold increase comparedto the initial height H of 10.7 mm). It should be understood that theforegoing data is just one example and that inflatable bladders can bedesigned to meet virtually any desired specifications. In some cases,when the interior space of the inflatable bladder 800 is filled, thepressure-exerting surface 824 will naturally tend to bulge outwardslightly.

While in the depicted embodiment the dimensions of the two stages ofexpansion of the inflatable bladder 800 are about equal, such anarrangement is not required in all embodiments. For example, in someembodiments one or more stages of expansion can be a lesser distancethan one or more other stages of expansion. The extent of expansions(dimensionally), relating to stages of expansion, can be controlled bythe size of the undulation(s) of the peripheral side wall 822. The sizesof the undulations of an inflatable bladder do not need to all be thesame size in a particular embodiment of the inflatable bladder 800.

Referring to FIG. 27, some embodiments of the inflatable bladdersdescribed herein (such as the depicted example inflatable bladder 900having an undulated peripheral side wall 922) have a pressure-exertingsurface 924 with a layer of fabric 926 attached thereto. The layer offabric 926 can serve to promote tissue ingrowth and/or fibrosis of theepicardium. Accordingly, the attachment of the pressure-exerting surface924 to the epicardial surface of a heart is thereby enhanced. Forexample, in some cases an inflatable bladder with a layer of fabric 926attached to the pressure-exerting surface 924 is implanted adjacent to aheart. Then, prior to inflation of the inflatable bladder, the layer offabric 926 is allotted time to attach to the epicardium by way of tissueingrowth and/or fibrosis. The allotted time may be 1 week, 2 weeks, 3weeks, 4 weeks, 5 weeks, 6 weeks, or more than 6 weeks, and any timeperiod therebetween. After the allotted time for tissue ingrowth and/orfibrosis has occurred, then the inflatable bladder is inflated.

The layer of fabric 926 can be made of any suitable material such as,but not limited to, Denier polyester, polytetrafluoroethylene (PTFE),expanded PTFE (ePTFE), polypropylene, and the like. In some cases, thelayer of fabric 926 can be treated with chemical moieties to enhancetissue ingrowth and/or endothelialization.

Referring back to FIG. 1A, and as described above, the inflation tube130 is in fluid communication with the fillable bladder 120. Theinflation tube 130 provides a lumen through which an inflation fluid(e.g., saline or another biocompatible liquid) is transferred to therebyinflate or deflate the fillable bladder 120. In some embodiments, theinflation fluid can be a phase-change material. For example, thephase-change material can be injected as a fluid, and can become agel-like substance or a solid at or around body temperature (e.g.,approximately 97.7-99.5° F., 36.5-37.5° C.). In some embodiments, theinflation fluid can be injected at a temperature lower or higher thanbody temperature, and become a gel-like substance or a solid at oraround body temperature. Such an inflation fluid can be advantageousbecause in the unlikely event that the fillable bladder 120 develops aleak, a gel-like or solid inflation medium will be less likely to leakor escape from the fillable bladder 120.

In some cases, the phase-change material used as the inflation fluid forthe fillable bladder 120 can be a polymer with a stronglytemperature-dependent modulus. In one non-limiting example, Calo-MER™shape-memory thermoplastics can be produced with a transitiontemperature between −40 and 70° C., to a tolerance of ±2° C.Accordingly, a suitable Calo-MER™ shape-memory thermoplastic can beproduced with a transition temperature at or near normal bodytemperature (e.g., approximately 97.7-99.5° F., 36.5-37.5° C.). Inaddition, other phase-change materials such as, but not limited to,paraffin, poloxamer, polymers, or a combination thereof can be used asthe inflation fluid. Such phase-change materials can be injected intothe fillable bladder 120 as a liquid. Thereafter, in-situ, thephase-change material will transition to become a gel-like substance ora solid substance.

Referring to FIG. 28, the implant 100 (e.g., of FIG. 2A) can include thegenerally cylindrical leading end portion 114 that provides the largestdiameter of the three portions 114, 116, and 118 (when the implant 100is in a non-stressed state prior to implantation). In some embodiments,at least a portion of the leading end portion 114 has a diameter andconstruction for positioning around a heart in the atrial-ventriculargroove AV of the heart H. The implant 100 can include the fillablebladder 120, which as previously described, can be used to exert alocalized pressure on a surface of the heart to induce a therapeuticdeflection thereto.

In some embodiments, the fillable bladder 120 is configured of twodifferent sheet components, an interior sheet component and an exteriorsheet component, so that the bladder 120, when inflated, expands moreinteriorly (that is, toward the heart wall when implanted) thanexteriorly. As such, the bladder 120 is configured to provide adifferential compliance in which one surface of a bladder 120 issignificantly more compliant than the opposing (less compliant) surfaceof the bladder 120. In the context of fillable bladder 120, the interiorsheet component of the fillable bladder 120 is more compliant than theouter sheet component of the fillable bladder 120. When the implant 100is implanted on a heart, the heart is located within the interior regionof the mesh body 110 and in contact with the interior sheet component ofthe fillable bladder 120. The greater compliance of the interior sheetcomponent of the fillable bladder 120 (in relation to the lessercompliance of the outer surface material) can accentuate the localizedpressure applied onto the surface of the heart when the fillable bladder120 is inflated.

In some embodiments, the implant 100 can include one or more sensors150, located at various locations of the implant 100. In someembodiments, the sensor(s) 150 can be one or more piezoelectric crystalsor other types of acoustic sensors (e.g., ultrasound), such thatsonomicrometry can be used to determine a distance between two sensors150. For example, acoustic signals can be transmitted and receivedbetween the sensors 150 to determine the distance between the sensors.

In some embodiments, first sensor 150 can be located on a sheetcomponent of the fillable bladder 120. For example, the first sensor 150can be located on an internal portion of the outer sheet component, onan external portion of the outer sheet component, on an internal portionof the interior sheet component, or on an external portion of theinterior sheet component. In addition, a second sensor can be located ona second sheet portion of the fillable bladder 120 different than thelocation of the first sensor 150. For example, if the first sensor 150is located on the outer sheet component, the second sensor can belocated on the inner sheet component, or vice-versa. Optionally, asecond, or third, sensor can be located on a portion of the implant 100(e.g., the cylindrical leading end portion 114) that is generallyopposite the fillable bladder 120.

In some embodiments, the sensors 150 can be used to determine a distancebetween two of the sensors 150. Optionally, the distance between two ofthe sensors 150 can provide a diameter of the implant 100, andaccordingly, a distance relating to the heart of the patient. In someembodiments, a first distance between the sensors 150 can be initiallymeasured once the fillable bladder 120 is filled with fluid, and asecond distance can measured a period of time after the fillable bladder120 is filled to monitor changes in the distance. The second distancecan be compared to the first distance to determine if the distancebetween the sensors 150 (e.g., the distance between the interior sheetcomponent and the exterior sheet component, or the distance between thefillable bladder 120 and the portion of the implant that is opposite thefillable bladder 120) has changed. The second distance measurements canbe taken periodically, for example, continuously, multiple times persecond, multiple times per minute, multiple times per hour, or atanother frequency. Optionally, the distance between the sensors can beused to determine if fluid in the fillable bladder 120 has leaked out ofthe fillable bladder 120. For example, by determining a decrease in thedistance between the interior sheet component and the exterior sheetcomponent, leakage may be concluded as compression of the heart isreduced. In some embodiments, by determining an increase in the distancebetween the fillable bladder 120 and the portion of the implant that isopposite the fillable bladder 120, leakage may be determined. Loss offluid can be problematic because as fluid is lost, the size of thefillable bladder 120 may decrease, resulting in an increase of thedistance across the heart. Accordingly, the localized pressure and/orcompression of the heart may decrease, reducing an efficacy of theimplant 100.

In some embodiments, the sensor(s) 150 communicate with an implanteddevice (e.g., a controller, processor, etc.) during monitoring, and whena difference between the first distance and the second distance isdetected, the implanted device communicates with an external device(e.g., a mobile device, a monitoring device, a telemetry wand, or othertype of external device capable of communicating with an implanteddevice). For example, a message (e.g., an alert or notification) may besent to the external device to inform a user that fluid should be addedto the fillable bladder 120. In some embodiments, when the firstdistance and the second distance are compared, the difference can becompared to a threshold value. In some embodiments, the threshold valuecan be selected to account for differences between the first distanceand the second distance that are likely due to contraction andrelaxation of the heart as the heart beats. Optionally, the thresholdvalue can be selected to indicate substantial changes that would requireadditional fluid to be added to fillable bladder 120, as some reductionsin fluid volume may be substantially negligible with regard to efficacyof the implant 100. For example, the implementation of the thresholdvalue may reduce the occurrence of false positives and/or over inflationof the fillable bladder 120 as fluid may be added with everynotification of potential leakage.

Referring to FIGS. 29 and 30, an example positioning tool 1000 with afillable bladder 1020 can be used prior to implantation of the cardiacimplant devices (jackets) described herein. For example, positioningtool 1000 and fillable bladder 1020 can be used to determine a locationand/or amount of fluid (e.g., level of inflation) for fillable bladder120 on implant 100, to provide increased efficacy of implant 100.Fillable bladder 1020 is designed to have an extra-low profile whenuninflated, and to be highly expandable in response to inflation. Toachieve the highly expandable design, the fillable bladder 1020 hasspecial side walls that are formed with undulations like a bellows. Suchside walls make fillable bladder 1020 highly expandable.

The fillable bladder 1020 can be made of any of the materials, shapes,and can be made using any of the construction techniques that aredescribed above in reference to fillable bladders, such as the fillablebladders 20, 120, and 800. In some cases, an inner layer of the fillablebladder 1020 (e.g., facing the heart) is more compliant than an outerlayer of the fillable bladder 1020 (e.g., facing away from the heart).Alternatively, in some cases the inner and outer layers of the fillablebladder 1020 are made of materials having the same compliance. In somesuch cases, the fillable bladder 1020 is expandable without stretchingthe materials of the layers. Such a design can provide enhanced fatigueresistance and predictable expansion of the fillable bladder 1020 insome cases.

Referring also to FIG. 31, the fillable bladder 1020 (shown here in atransverse cross-section view) includes a base layer 1022 (e.g., anouter layer) and an expanding layer 1024 (e.g., an inner layer). Thebase layer 1022 and the expanding layer 1024 are bonded together (in asealed manner) around the periphery of the fillable bladder 1020. Insome embodiments, an intermediate layer is interposed between the baselayer 1022 and the expanding layer 1024 around the periphery of thefillable bladder 1020. An inflation tube 1006, which is in fluidcommunication with an interior space of the bladder that is definedbetween the base layer 1022 and the expanding layer 1024, extendstherefrom. The inflation tube 1006 is used to convey an inflation fluid(e.g., saline or another biocompatible liquid) into and/or out of thefillable bladder 1020.

The expanding layer 1024 includes a peripheral side wall 1028 and apressure-exerting surface 1026 positioned within the periphery of theperipheral side wall 1028. The pressure-exerting surface 1026 isgenerally planar in some embodiments. The peripheral side wall 1028includes one or more undulations (e.g., one, two as shown, three, four,five, six, or more than six undulations). The undulations act like thefolds of a bellows (or an accordion) to allow the fillable bladder 1020to transition between a low profile (as shown) to a substantiallyexpanded profile (e.g., as shown in FIGS. 32 and/or 33). Moreover, thetransition between a low profile to a substantially expanded profile canbe accomplished without material stretching, if so desired.

Referring to FIG. 32, the fillable bladder 1020 is again shown in atransverse cross-section view. Here, however, the fillable bladder 1020has been inflated so that it is enlarged to a first expanded size. Inthis first expanded size, one of the undulations (e.g., folds) of theperipheral side wall 1028 has unfolded in response to a pressureincrease in the interior space of the fillable bladder 1020 from aninfilling of an inflation fluid. As a result, the pressure-exertingsurface 1026 has moved away from the base layer 1022. In this manner,pressure can be exerted by fillable bladder 1020 to a heart wall tomodulate conditions such as FMR.

Referring also to FIG. 33, if additional inflation fluid is added to theinterior space of the fillable bladder 1020, the pressure-exertingsurface 1026 will move still farther away from the base layer 1022. Inthe depicted arrangement, for example, the second undulation (e.g.,fold) of the peripheral side wall 1028 has unfolded in response to apressure increase in the interior space of the fillable bladder 1020from an additional infilling of an inflation fluid (in comparison to thearrangement of FIG. 32). It should be understood that, in someembodiments, the expansion of the fillable bladder 1020 as shown canoccur without extension (e.g., stretching or elongation) of thematerials of the pressure-exerting surface 1026 and the base layer 1022.

Similar to inflatable bladder 800, in one example embodiment of thefillable bladder 1020, the relationship between the volume of theinterior space of the fillable bladder 1020 and the height H of thefillable bladder 1020 is as follows: when the volume is 20 ml the heightH is 10.7 mm, when the volume is 40 ml the height H is 18.3 mm, when thevolume is 60 ml the height H is 27.4 mm, when the volume is 80 ml theheight H is 36.8 mm, when the volume is 90 ml the height H is 41.9 mm,and when the volume is 100 ml the height H is 44.2 mm (a more thanfour-fold increase compared to the initial height H of 10.7 mm). Itshould be understood that the foregoing data is just one example andthat inflatable bladders can be designed to meet virtually any desiredspecifications. In some cases, when the interior space of the fillablebladder 1020 is filled, the pressure-exerting surface 1026 willnaturally tend to bulge outward (e.g., toward the heart) slightly.

While in the depicted embodiment the dimensions of the two stages ofexpansion of the fillable bladder 1020 are about equal, such anarrangement is not required in all embodiments. For example, in someembodiments one or more stages of expansion can be a lesser distancethan one or more other stages of expansion. The extent of expansions(dimensionally), relating to stages of expansion, can be controlled bythe size of the undulation(s) of the peripheral side wall 1028. Thesizes of the undulations of an inflatable bladder do not need to all bethe same size in a particular embodiment of the fillable bladder 1020.

Referring to FIG. 34, an example method 1100 for using the positioningtool 1000 of FIG. 29 can include inserting the positioning tool 1000into the pericardial cavity at 1102, positioning the fillable bladder1020 at a first location at 1104, injecting fluid into the fillablebladder 1020 at 1106, monitoring the patient at 1108, modifying alocation of the fillable bladder 1020 and/or an amount of fluid in thefillable bladder 1020 at 1110, and determining a location and amount offluid in the fillable bladder 1020 at 1112.

At step 1102, in some implementations of the method 1100, thepositioning tool 1000 can be inserted into the pericardial cavity. Thisstep of inserting the positioning tool 1000 into the pericardial cavitycan include selecting a location for an incision to access the patient'sheart, and then making an incision through the patient's skin. In someembodiments, the selected location of the incision will allow access tothe apex of the heart in alignment with the long axis of the heart. Suchan incision can allow the positioning tool 1000 to be inserted into thepatient's chest cavity substantially coaxially with the heart.Therefore, the location for the incision can be made at least partlybased on the location of the apex of the patient's heart. In someimplementations, an intercostal incision location is selected. Forexample, in particular implementations the fifth intercostal space maybe selected. However, the selected incision location can bepatient-specific. In some implementations, the incision comprises amini-thoracotomy heart-access procedure. In some embodiments of method1100, a minimum size of incision is recommended. In some cases, theincision can be made such that the delivery device 200 described abovecan fit into the incision after method 1100 is complete. For example,for the delivery device 200 described above, a minimum incision of 7 cmis recommended, although that is optional in some implementations.

In some embodiments, inserting the positioning tool 1000 into thepericardium at step 1102 can include surgical retraction. Surgicalretraction can be performed to create and maintain a surgical passagewaythrough the patient's incised skin. In some implementations, alow-profile retractor is used. In some embodiments of method 1100, aseparation distance of the retractor blades is recommended.

In addition, inserting the positioning tool 1000 into the pericardium atstep 1102 can include incising and retracting the pericardium to provideaccess to the heart's apex. In some embodiments, the selected locationof the incision will allow access to the apex of the heart in alignmentwith the long axis of the heart. In some embodiments of method 1100, aminimum size of incision is recommended. The edges of the pericardiumcan be retracted by suturing the edges to the surrounding tissues.

At step 1104, in some implementations of the method 1100, the fillablebladder 1020 of the positioning tool 1000 can be positioned at a firstlocation. The fillable bladder 1020 is aligned adjacent to a targetlocation on the heart. For example, in some instances the targetlocation may be on the posterior lateral surface of the heart where thefillable bladder will be able to deflect the “P2” portion of theposterior leaflet of the mitral valve to treat FMR. Other targetlocations may be selected in other instances depending on the conditionto be treated after implantation of the implant 100 using method 300described above.

At step 1106, in some implementations of the method 1100, fluid can beinjected into the fillable bladder 1020. Sterile saline solution orother types of inflation fluids may be used to inflate the fillablebladder 1020. For example, the inflation fluid can be dispensed from asyringe device or other inflation delivery device that is temporarilycoupled to the proximal end opening of the tube 1006.

At step 1108, in some implementations of the method 1100, hemodynamicsof the patient is/are monitored. When the condition being treated isvalvular regurgitation, the valve may be monitored using, for example,transesophageal echocardiography or other like techniques, while theinflation is taking place and/or being adjusted. Such contemporaneousmonitoring may assist the clinician to determine the volume of inflationfluid to administer into the fillable bladder(s) and the efficacy ofvarious positions relative to the heart.

At optional step 1110, in some implementations of the method 1100, alocation of the fillable bladder 1020 and/or an amount of fluid in thefillable bladder 1020 can be modified. If the desired results are notobtained when monitoring the valve/hemodynamics, the amount of fluid inthe fillable bladder 1020 can be modified (e.g., increased ordecreased). Further, if the desired results are not obtained whenmonitoring the valve, the location of the fillable bladder 1020 can bemodified. As the amount of fluid in the fillable bladder 1020 ismodified, and/or the location of the fillable bladder 1020 is modified,the patient can continue to be monitored.

At step 1112, in some implementations of the method 1100, the locationand amount of fluid in the fillable bladder 1020 can be determined. Insome cases, the location and amount of fluid in the fillable bladder1020 is determined once patient monitoring shows a desired result or aoptimal result. In some cases, the desired result is improvedfunctioning of the valve (e.g., reduced MR). The location and amount offluid in the fillable bladder 1020 determined from the use of thepositioning tool 1000 via method 1100 can be used to determine theplacement and inflation fluid amounts to use when positioning implant100 on the heart of the patient.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the scope of the invention. Accordingly,other embodiments are within the scope of the following claims.

1. A cardiac implant for implantation around an exterior of a heart, theimplant comprising: an implant body comprising a mesh material that isformed into a generally tubular configuration, the implant bodycomprising a leading end portion defining an open leading end and atrailing end portion defining an open trailing end of a diameter that isless than a diameter of the open leading end; a fillable bladder with abase layer and an expanding layer, wherein the fillable bladder ismounted to the implant body and positioned relative to the open leadingend such that, when the leading end portion is positioned in anatrial-ventricular groove of the heart, the fillable bladder ispositionable on an exterior of a heart wall; and a first sensor mountedat a first location on the cardiac implant.
 2. The cardiac implant ofclaim 1, wherein the first sensor is a piezoelectric sensor.
 3. Thecardiac implant of claim 1, further comprising a second sensor mountedat a second location on the cardiac implant.
 4. The cardiac implant ofclaim 3, wherein the first sensor in mounted on the fillable bladder andthe second sensor is mounted on a portion of the implant body oppositethe fillable bladder.
 5. The cardiac implant of claim 3, wherein thefirst sensor is mounted on the base layer of the fillable bladder andthe second sensor is mounted on the expanding layer of the fillablebladder.
 6. The cardiac implant of claim 3, wherein a distance ismeasured between the first sensor and the second sensor. 7-12.(canceled)
 13. A cardiac implant for implantation around an exterior ofa heart, the implant comprising: an implant body comprising a meshmaterial that is formed into a generally tubular configuration, theimplant body comprising a leading end portion defining an open leadingend and a trailing end portion defining an open trailing end of adiameter that is less than a diameter of the open leading end; afillable bladder mounted to the implant body and positioned relative tothe open leading end such that, when the leading end portion ispositioned in an atrial-ventricular groove of the heart, the fillablebladder is positionable on an exterior of a heart wall; and aphase-change material configured to be injected into the fillablebladder.
 14. The cardiac implant of claim 13, wherein the phase-changematerial is configured to be injected into the fillable bladder as aliquid and to solidify at body temperature.
 15. The cardiac implant ofclaim 13, wherein the phase-change material is a polymer with a stronglytemperature dependent modulus. 16-19. (canceled)
 20. A cardiac implantpositioning tool for implantation around an exterior of a heart, theimplant comprising: a handle having a proximal end portion and a distalend portion; a fillable bladder coupled to the distal end portion of thehandle such that, when the distal end portion of the handle ispositioned in an atrial-ventricular groove of the heart, the fillablebladder is positionable on an exterior of a heart wall; and a tubefluidly coupled to the fillable bladder and extending to the proximalend portion of the handle.
 21. The cardiac implant positioning tool ofclaim 20, wherein the fillable bladder includes side walls with one ormore undulations.
 22. The cardiac implant positioning tool of claim 21,wherein the side walls with one or more undulations facilitate expansionof the fillable bladder without stretching. 23-26. (canceled)